Trial · Observational
CompletedPhase not statedResults postedRegistry dataShort name Care
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The objective of this follow-up study is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is safe for pregnant participants and their offspring.
Other
Corifollitropin alfa 100 μg
In follow-up study, no medication or investigational product was administered. In base study P05690 (NCT00702845), participants received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants in base study P05690 also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular \[IM\] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.
Other
recFSH 150 IU
In follow-up study, no medication or investigational product was administered. In base study P05690 (NCT00702845), participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
Outcomes the sponsor listed as primary.
Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)
Time frame · From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)
The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.
Number of Expectant Mothers Experiencing Adverse Events (AEs)
Time frame · From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Number of Expectant Mothers Experiencing Serious AEs (SAEs)
Time frame · From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Number of Infants Experiencing AEs
Time frame · Up to 12 weeks after birth
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Number of Infants Experiencing SAEs
Time frame · Up to 12 weeks after birth
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage of participants) |
|---|---|
| Corifollitropin Alfa 100 μg Women | 23.5 |
| recFSH 150 IU Women | 34.4 |
| Group | Value (Participants) |
|---|---|
| Corifollitropin Alfa 100 μg Expectant Mothers | 48 |
| recFSH 150 IU Expectant Mothers | 35 |
| Group | Value (Participants) |
|---|---|
| Corifollitropin Alfa 100 μg Expectant Mothers | 38 |
| recFSH 150 IU Expectant Mothers | 21 |
| Group | Value (Live born infants) |
|---|---|
| Corifollitropin Alfa 100 μg Follow-Up Infants | 37 |
| recFSH 150 IU Follow-Up Infants | 27 |
| Group | Value (Live born infants) |
|---|---|
| Corifollitropin Alfa 100 μg Follow-Up Infants | 30 |
| recFSH 150 IU Follow-Up Infants | 16 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Corifollitropin Alfa 100 μg Expectant MothersParticipants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular \[IM\] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given. | – | 38 / 68 | 13 / 68 |
| recFSH 150 IU Expectant MothersParticipants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given. | – | 21 / 45 | 17 / 45 |
| Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ETThis group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710. | – | 31 / 88 | 9 / 88 |
| recFSH 150 IU Fetuses at 10 Weeks After ETThis group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710. | – | 16 / 55 | 5 / 55 |
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