Efficacy and Safety of FE 999049 in Controlled Ovarian St... | NCT04773353

NCT04773353

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Follitropin Delta (FE 999049)	Experimental	Recombinant follicle-stimulating hormone (rFSH). Follitropin delta for subcutaneous injection	Drug: Follitropin Delta (FE 999049)
Follitropin Alfa (GONAL-F)	Experimental	rFSH. Follitropin alfa for subcutaneous injection	Drug: Follitropin Alfa (GONAL-F)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Follitropin Delta (FE 999049)	Drug	FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. For participants with low AMH (<15 pmol/L) the daily FE 999049 dose was 12 μg, irrespective of body weight. For participants with high AMH (≥15 pmol/L) the daily FE 999049 dose was on a continuous scale ranging from 0.19 to 0.10 μg/kg, i.e. dependent on actual AMH and body weight. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 12 μg. Participants could be treated for a maximum of 20 days.

Measure	Description	Time Frame
Ongoing pregnancy rate	Ongoing pregnancy is defined as at least one intrauterine viable fetus 10-11 weeks after embryo transfer.	10-11 weeks after embryo transfer

Measure	Description	Time Frame
Positive beta human chorionic gonadotropin (βhCG) rate	Positive βhCG is defined as positive serum βhCG test 13-15 days after embryo transfer.	13-15 days after embryo transfer
Clinical pregnancy rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed Consent Forms signed prior to screening evaluations.
In good physical and mental health as judged by the investigator.
Indian (i.e., possessing an Indian identification card and having native Indian parents) pre-menopausal females between the ages of 21 and 40 years. The participants must be at least 21 years (including the 21st birthday) when they sign the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomization.
Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II (defined by the revised American Society for Reproductive Medicine [ASRM] classification, 1996) or with partners diagnosed with male factor infertility, eligible for in vitro fertilization (IVF) and/or ICSI using fresh or frozen ejaculated sperm from male partner or sperm donor.
Infertility for at least one year before randomization for participants <35 years or for at least 6 months for participants ≥35 years (not applicable in case of tubal or severe male factor infertility).
The trial cycle will be the participant's first controlled ovarian stimulation cycle for IVF/ICSI.
Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
Hysterosalpingography, hysteroscopy, saline infusion sonography, or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to randomization.
Transvaginal ultrasound documenting presence and adequate visualization of both ovaries, without evidence of significant abnormality (e.g., enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g., no hydrosalpinx) within 1 year prior to randomization. Both ovaries must be accessible for oocyte retrieval.
Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L (results obtained within 3 months prior to randomization).
Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests within 1 year prior to randomization.
Body mass index (BMI) between 17.5 and 32.0 kg/m^2 (both inclusive) at screening.
Willing to accept transfer of 1-2 embryos.

Exclusion Criteria:

Known endometriosis stage III-IV (defined by the revised ASRM classification, 1996).
One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound prior to randomization on stimulation day 1 (puncture of cysts is allowed prior to randomization).
Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy [excluding ectopic pregnancy] and before Week 24 of pregnancy).
Known abnormal karyotype of participant or of her partner/sperm donor, as applicable, depending on source of sperm used for insemination in this trial.
Any known clinically significant systemic disease (e.g., insulin-dependent diabetes).
Known inherited or acquired thrombophilia disease.
Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
Known porphyria.
Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of controlled thyroid function disease.
Known presence of anti-FSH antibodies (based on the information available in the participant's medical records).
Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
Known moderate or severe impairment of renal or hepatic function.
Any abnormal finding of clinical chemistry, haematology or vital signs at screening which is clinically significant as judged by the investigator.
Currently breast-feeding.
Undiagnosed vaginal bleeding.
Known abnormal cervical cytology of clinical significance observed within 3 years prior to randomization (unless the clinical significance has been resolved).
Findings at the gynecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g., congenital uterine abnormalities or retained intrauterine device.
Pregnancy (negative urinary pregnancy tests must be documented at screening and prior to randomization) or contraindication to pregnancy.
Known current active pelvic inflammatory disease.
Use of fertility modifiers during the last menstrual cycle before randomization, including dehydroepiandrosterone (DHEA), metformin or cycle programming with oral contraceptives, progestogen or estrogen preparations.
Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle before randomization.
Known history of chemotherapy (except for gestational conditions) or radiotherapy.
Current or past (1 year prior to randomization) abuse of alcohol or drugs.
Current (last month) intake of more than 14 units of alcohol per week.
Current or past (3 months prior to randomization) smoking habit of more than 10 cigarettes per day.
Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial.
Previous participation in the trial.
Use of any non-registered investigational drugs during the last 3 months prior to randomization.

Facility	Status	City	State	ZIP	Country	Contacts
Ferring Investigational Site		Ahmedabad	Gujarat		India
Ferring Investigational Site

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
C000620228	follitropin delta
C000608977	FE 999049
C571801	follitropin alfa