A Randomised Trial Comparing the Ovarian Response of a St... | NCT06173869

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FE 999049	Experimental	The participants receive either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg	Drug: FE 999049
GONAL-F	Active Comparator	The participants receive either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU.	Drug: GONAL-F

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FE 999049	Drug	FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose could be increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants could be treated for a maximum of 20 days.

Measure	Description	Time Frame
Number of Oocytes Retrieved		On day of oocyte retrieval (up to 22 days after start of stimulation)

Measure	Description	Time Frame
Number of Follicles on Stimulation Day 6 and End-of-stimulation		Stimulation day 6 and end-of-stimulation (maximum stimulation day 20)
Serum Concentrations of Estradiol on Stimulation Day 6 and End-of-stimulation		stimulation day 6 and end-of-stimulation (maximum stimulation day 20)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed and dated Informed Consent Form for participation in the trial, obtained before any trial-related procedures.
In good physical and mental health in the judgement of the investigator.
Chinese pre-menopausal female between the ages of 20 and 40 years; at least 20 years (including the 20th birthday) when signing the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomisation.
Eligible for ovarian stimulation with a dose equivalent to 150 IU GONAL-F or 225 IU GONAL-F, as judged by the investigator.
Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.
Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor
Infertility for at least one year before randomisation for subjects <35 years or for at least 6 months for subjects ≥35 years (criteria not applicable in case of tubal or severe male factor infertility).
Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality. Both ovaries must be accessible for oocyte retrieval.
Early follicular phase (cycle day 2-4) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (results obtained within 3 months prior to randomisation).
Serum anti-Müllerian hormone (AMH) concentration of ≤35 pmol/L at screening.

Exclusion Criteria:

Primary ovarian failure.
More than three previous controlled ovarian stimulation cycles initiated, regardless of outcome.
History of previous episode of OHSS, exuberant ovarian response to gonadotropins, or polycystic ovarian syndrome.
Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial with the exception of controlled thyroid function disease.
Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
Fibroid tumours of the uterus incompatible with pregnancy.
Currently breast-feeding.
Known inherited or acquired thrombophilia disease.
Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
Known porphyria.

Name	Affiliation	Role
Global Clinical Compliance	Ferring Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Ferring Investigational Site		Shushan	Anhui	230032	China
Ferring Investigational Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 19, 2023

Arm/Group Information

ID	Title	Description
BG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
BG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000148 BG001153 BG002301

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00032.5± 3.6 BG00132.2± 3.8 BG00232.3± 3.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000148 BG001153 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

China

Title	Measurements
	BG000148 BG001153 BG002

Dose Group

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Low Starting Dose	BG00047 BG00151 BG002

Body Measurement (Weight)

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00057.5± 8.3 BG00157.5± 7.7 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Oocytes Retrieved

Posted

Mean

Standard Deviation

Oocytes retrieved

On day of oocyte retrieval (up to 22 days after start of stimulation)

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Units	Counts
Participants	OG000148 OG001153

Title

Denominators

Categories

Title	Measurements
	OG00012.7± 5.2 OG00111.8± 5.3

Secondary

Number of Follicles on Stimulation Day 6 and End-of-stimulation

Posted

Mean

Standard Deviation

Follicles

Stimulation day 6 and end-of-stimulation (maximum stimulation day 20)

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Serum Concentrations of Estradiol on Stimulation Day 6 and End-of-stimulation

Posted

Mean

Standard Deviation

pmol/L

stimulation day 6 and end-of-stimulation (maximum stimulation day 20)

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Serum Concentrations of Progesterone on Stimulation Day 6 and End-of-stimulation

Posted

Mean

Standard Deviation

nmol/L

stimulation day 6 and end-of-stimulation (maximum stimulation day 20)

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Number of Fertilised Oocytes

Posted

Mean

Standard Deviation

Fertilised Oocytes

On day 1 after oocyte retrieval (up to 23 days after start of stimulation)

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Fertilisation Rate

Posted

Mean

Standard Deviation

percentage of fertilised oocytes

On day 1 after oocyte retrieval (up to 23 days after start of stimulation)

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Number of Embryos (Total and Quality)

Posted

Mean

Standard Deviation

Embryos

Day 3 after oocyte retrieval

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Total Gonadotropin Dose

Posted

Mean

Standard Deviation

Up to 20 stimulation days

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Number of Stimulation Days

Posted

Mean

Standard Deviation

days

Up to 20 stimulation days

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Positive βhCG (Positive Serum βhCG Test 13-15 Days After Transfer) Rate

Posted

Count of Participants

Participants

13-15 days after transfer

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Clinical Pregnancy (at Least One Gestational Sac 5-6 Weeks After Transfer) Rate

Posted

Count of Participants

Participants

5-6 weeks after transfer

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Vital Pregnancy (at Least One Intrauterine Gestational Sac With Fetal Heart Beat 5-6 Weeks After Transfer) Rate

Posted

Count of Participants

Participants

5-6 weeks after transfer

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Implantation Rate

The implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred.

Total Number of gestational sacs (subject level)

Posted

Number

percentage of embryos transferred

5-6 weeks after transfer

Number of transferred embryos

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Ongoing Pregnancy (at Least One Intrauterine Viable Fetus 10-11 Weeks After Transfer) Rate

Posted

Count of Participants

Participants

10-11 weeks after transfer

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Ongoing Implantation Rate (Number of Intrauterine Viable Fetuses 10-11 Weeks After Transfer Divided by Number of Embryos Transferred)

The ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by the number of embryos transferred.

Low starting dose: 10 μg FE 999049 or 150 IU GONAL-F, high starting dose: 15 μg FE 999049 or 225 IU GONAL-F

Posted

Number

percentage of embryos transferred

10-11 weeks after transfer

Number of transferred embryos

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Secondary

Early Ovarian Hyperstimulation Syndrome (OHSS), Late OHSS, and Total OHSS (All Overall and by Grade)

Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation. Total OHSS measure the incidence of OHSS both early and late.

Posted

Count of Participants

Participants

≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS)

ID	Title	Description
OG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
OG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FE 999049	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.	0	148	4	148	16	148
EG001	GONAL-F	The participants received either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days. Coasting was not allowed.	0	153	11	153	25	153

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Bartholin's abscess	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected153 at risk
Dengue Fever	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected153 at risk
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG0001 events1 affected148 at risk EG0014 events4 affected153 at risk
Abortion Threatened	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG0001 events1 affected148 at risk EG0013 events3 affected153 at risk
Ectopic Pregnancy	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG0000 events0 affected148 at risk EG0013 events3 affected153 at risk
Ovarian Hyperstimulation Syndrome	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 events1 affected148 at risk EG0012 events2 affected153 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG00010 events9 affected148 at risk EG0015 events5 affected153 at risk
Biochemical Pregnancy	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG0008 events8 affected148 at risk EG00115 events15 affected153 at risk
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG0008 events8 affected148 at risk EG0015 events5 affected153 at risk
Morning Sickness	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG00018 events12 affected148 at risk EG00115 events10 affected153 at risk
Hydrometra	Reproductive system and breast disorders	Non-systematic Assessment	EG0009 events9 affected148 at risk EG0018 events7 affected153 at risk
Pelvic discomfort	Reproductive system and breast disorders	Non-systematic Assessment	EG0008 events8 affected148 at risk EG0018 events8 affected153 at risk

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D007246	Infertility

ID	Term
C000608977	FE 999049
C000620228	follitropin delta
C571801	follitropin alfa