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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000633-36 | EudraCT Number |
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This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5.2 µg | Experimental |
| |
| 6.9 µg | Experimental |
| |
| 8.6 µg | Experimental |
| |
| 10.3 µg | Experimental |
| |
| 12.1 µg | Experimental |
| |
| 11 µg FbM (150 IU) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FE 999049 | Drug |
| ||
| Gonal - F |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Oocytes Retrieved | Day of oocyte retrieval (up to Day 18 after start of stimulation) |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Size of Follicles During Stimulation | Follicular volume at end of stimulation | End of stimulation (up to 16 stimulation days) |
| Endocrine Profile | Estradiol at end of stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | Belgium | ||||
| UZ Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32819842 | Result | Arce JC, Larsson P, Garcia-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online. 2020 Oct;41(4):616-622. doi: 10.1016/j.rbmo.2020.07.006. Epub 2020 Jul 15. | |
| 25256937 | Derived | Arce JC, Andersen AN, Fernandez-Sanchez M, Visnova H, Bosch E, Garcia-Velasco JA, Barri P, de Sutter P, Klein BM, Fauser BC. Ovarian response to recombinant human follicle-stimulating hormone: a randomized, antimullerian hormone-stratified, dose-response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection. Fertil Steril. 2014 Dec;102(6):1633-40.e5. doi: 10.1016/j.fertnstert.2014.08.013. Epub 2014 Sep 23. |
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In total 334 subjects were screened. Of these, 69 were screening failures and 265 were randomised. All randomised subjects were exposed to investigational medicinal product (IMP).
A total of 7 sites randomised subjects to the trial: 1 in Belgium, 1 in Czech Republic, 1 in Denmark and 4 in Spain.
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| ID | Title | Description |
|---|---|---|
| FG000 | FE 999049 5.2 µg | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days |
| FG001 | FE 999049 6.9 µg | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days |
| FG002 | FE 999049 8.6 µg | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days |
| FG003 | FE 999049 10.3 µg | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days |
| FG004 | FE 999049 12.1 µg | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days |
| FG005 | GONAL-F 11 µg | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FE 999049 5.2 µg | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days |
| BG001 | FE 999049 6.9 µg | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Modified Intention-to-treat (mITT) population (all randomised and exposed subjects). This is equivalent to the Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Oocytes | Day of oocyte retrieval (up to Day 18 after start of stimulation) |
|
From signing informed consent form until the end of trial visit (up to 5 months)
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| 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 5.2 µg | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000608977 | FE 999049 |
| D015292 | Glycoprotein Hormones, alpha Subunit |
| ID | Term |
|---|---|
| D006063 | Chorionic Gonadotropin |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Drug |
|
| End of stimulation (up to 16 stimulation days) |
| Total IMP Dose | End of stimulation (up to 16 stimulation days) |
| Number of Fertilised Oocytes | An oocyte with 2 pronuclei was regarded as correctly fertilised | Day 1 after insemination |
| Number and Quality of Blastocysts on Day 5 | Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher | Day 5 after oocyte retrieval |
| Clinical Pregnancy With Fetal Heart Beat Rate | Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat | 5-6 weeks after transfer |
| Frequency and Intensity of Adverse Events | From signing informed consent form until end of trial visit (up to 5 months) |
| Ghent |
| Belgium |
| ICF CUBE | Prague | Czechia |
| Rigshospitalet | Copenhagen | Denmark |
| IU Dexeus | Barcelona | Spain |
| IVI Madrid | Madrid | Spain |
| IVI Sevilla | Seville | Spain |
| IVI Valencia | Valencia | Spain |
| Did not attend scheduled visit |
|
| Poor response |
|
| Personal reasons |
|
| BG002 | FE 999049 8.6 µg | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days |
| BG003 | FE 999049 10.3 µg | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days |
| BG004 | FE 999049 12.1 µg | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days |
| BG005 | GONAL-F 11 µg | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days |
| OG003 | FE 999049 10.3 µg | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days |
| OG004 | FE 999049 12.1 µg | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days |
| OG005 | GONAL-F 11 µg | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days |
|
|
|
| Secondary | Number and Size of Follicles During Stimulation | Follicular volume at end of stimulation | mITT population (all randomised and exposed subjects). This is equivalent to the FAS | Posted | Mean | Standard Deviation | cm^3 | End of stimulation (up to 16 stimulation days) |
|
|
|
|
| Secondary | Endocrine Profile | Estradiol at end of stimulation | mITT population (all randomised and exposed subjects). This is equivalent to the FAS | Posted | Mean | Standard Deviation | pmol/L | End of stimulation (up to 16 stimulation days) |
|
|
|
|
| Secondary | Total IMP Dose | mITT population (all randomised and exposed subjects). This is equivalent to the FAS | Posted | Mean | Standard Deviation | µg | End of stimulation (up to 16 stimulation days) |
|
|
|
| Secondary | Number of Fertilised Oocytes | An oocyte with 2 pronuclei was regarded as correctly fertilised | Subjects with oocytes retrieved | Posted | Mean | Standard Deviation | Fertilised oocytes | Day 1 after insemination |
|
|
|
|
| Secondary | Number and Quality of Blastocysts on Day 5 | Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher | Subjects with oocytes retrieved | Posted | Mean | Standard Deviation | Blastocysts | Day 5 after oocyte retrieval |
|
|
|
| Secondary | Clinical Pregnancy With Fetal Heart Beat Rate | Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat | mITT population (all randomised and exposed subjects). This is equivalent to the FAS | Posted | Number | 95% Confidence Interval | percentage | 5-6 weeks after transfer |
|
|
|
|
| Secondary | Frequency and Intensity of Adverse Events | Safety population (all randomised and exposed subjects). This is equivalent to the mITT | Posted | Number | participants | From signing informed consent form until end of trial visit (up to 5 months) |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 11 |
| 42 |
| EG001 | FE 999049 6.9 µg | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days | 0 | 45 | 0 | 45 | 9 | 45 |
| EG002 | FE 999049 8.6 µg | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days | 0 | 44 | 0 | 44 | 11 | 44 |
| EG003 | FE 999049 10.3 µg | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days | 0 | 44 | 1 | 44 | 12 | 44 |
| EG004 | FE 999049 12.1 µg | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days | 0 | 47 | 0 | 47 | 11 | 47 |
| EG005 | GONAL-F 11 µg | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days | 0 | 43 | 0 | 43 | 4 | 43 |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 14.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D005640 | Follicle Stimulating Hormone |
| D006065 | Gonadotropins, Pituitary |
| D007986 | Luteinizing Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D013972 | Thyrotropin |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)
Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)
| Good quality blastocysts |
|
| Any moderate adverse events |
|
| Any severe adverse events |
|