An observational study in Pregnancy and Neonates, sponsored by Organon and Co. Completed. Open to female participants aged 18 Years to 36 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Organon and Co · Observational
The objective of this trial was to evaluate whether Corifollitropin Alfa 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) was safe for pregnant participants and their offspring. The primary endpoint was the take-home baby rate calculated as the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800) with at least one live born infant relative to the number of participants in the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer (ET).
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of all women who were treated with Corifollitropin Alfa or recFSH and became pregnant during Base Trial P05787 (NCT00696800). For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.
Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women with an ongoing pregnancy at least 10 weeks after ET in Base Trial P05787 (NCT00696800) were enrolled in this trial.
Puregon®/Follistim® AQ Cartridge in Base Trial P05787 (NCT00696800);
Exclusion Criteria:
Participants from the Base Trial P05787 who received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles \>= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Drug: Corifollitropin Alfa 150 μg · Drug: Placebo for RecFSH/Follitropin beta · Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG) · Drug: Ganirelix · Biological: hCG · Biological: Progesterone
Participants from the Base Trial P05787 who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7) · Drug: Placebo for Corifollitropin Alfa · Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG) · Drug: Ganirelix · Biological: hCG · Biological: Progesterone
In the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.
In the Base Trial P05787, daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
Also known as: follitropin beta, Puregon®, Follistim®
In the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection from a pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa was administered in the abdominal wall.
In the Base Trial P05787, daily SC injections of an identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen, were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
In the Base Trial P05787, from Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.
In the Base Trial P05787, on Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG.
In the Base Trial P05787, when 3 follicles \>= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
In the Base Trial P05787, on the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.
Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)
An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
Time frame: Up to one day following delivery (up to 1 year)
Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)
A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Time frame: Up to one day following delivery (up to 1 year)
Number of Infants Born in Current Follow Up Trial Experiencing AEs
An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
Time frame: Up to 12 weeks following delivery (up to 1 year)
Number of Infants in Current Follow Up Trial Experiencing SAEs
A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Time frame: Up to 12 weeks following delivery (up to 1 year)
Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.
The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.
Time frame: At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)
Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.
The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.
Time frame: At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)
| Milestone | Mothers Corifollitropin Alfa 150 µg | Mothers recFSH 200 IU | Fetuses/Infants Corifollitropin Alfa 150 µg | Fetuses/Infants recFSH 200 IU |
|---|---|---|---|---|
| Started | 757 | 752 | 0 | 0 |
| Treated | 756 | 750 | 0 | 0 |
| Embryo transfer | 672 | 704 | 0 | 0 |
| Completed | 295 | 286 | 0 | 0 |
| Not completed | 462 | 466 | 0 | 0 |
| Milestone | Mothers Corifollitropin Alfa 150 µg | Mothers recFSH 200 IU | Fetuses/Infants Corifollitropin Alfa 150 µg | Fetuses/Infants recFSH 200 IU |
|---|---|---|---|---|
| Started | 274 | 267 | 0 | 0 |
| Completed | 241 | 235 | 0 | 0 |
| Not completed | 33 | 32 | 0 | 0 |
| Withdrew: Did not complete follow up in p05712 | 33 | 32 | 0 | 0 |
| Milestone | Mothers Corifollitropin Alfa 150 µg | Mothers recFSH 200 IU | Fetuses/Infants Corifollitropin Alfa 150 µg | Fetuses/Infants recFSH 200 IU |
|---|---|---|---|---|
| Started | 0 | 0 | 352 | 326 |
| Live born infants | 0 | 0 | 344 | 315 |
| Completed | 0 | 0 | 305 | 284 |
| Not completed | 0 | 0 | 47 | 42 |
| Withdrew: Did not complete follow up in p05712 | 0 | 0 | 47 | 42 |
An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
| Participants | Mothers Corifollitropin Alfa 150 µg | Mothers recFSH 200 IU |
|---|---|---|
| Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) | 222 | 214 |
A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
| Participants | Mothers Corifollitropin Alfa 150 µg | Mothers recFSH 200 IU |
|---|---|---|
| Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs) | 129 | 117 |
An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
| Participants | Infants Corifollitropin Alfa 150 µg | Infants recFSH 200 IU |
|---|---|---|
| Number of Infants Born in Current Follow Up Trial Experiencing AEs | 164 | 161 |
A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
| Participants | Infants Corifollitropin Alfa 150 µg | Infants recFSH 200 IU |
|---|---|---|
| Number of Infants in Current Follow Up Trial Experiencing SAEs | 106 | 94 |
The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.
| Percentage of Participants | Mothers Corifollitropin Alfa 150 µg | Mothers recFSH 200 IU |
|---|---|---|
| Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial. | 35.6 | 34.4 |
The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.
| Percentage of Participants | Mothers Corifollitropin Alfa 150 µg | Mothers recFSH 200 IU |
|---|---|---|
| Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer. | 40.0 | 36.6 |
Collected over Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mothers Corifollitropin Alfa 150 µg | — | 129/274 (47.1%) | 112/274 (40.9%) |
| Mothers recFSH 200 IU | — | 117/267 (43.8%) | 118/267 (44.2%) |
| Fetuses/Infants Corifollitropin Alfa 150 µg | — | 106/352 (30.1%) | 37/352 (10.5%) |
| Fetuses/Infants recFSH 200 IU | — | 94/326 (28.8%) | 41/326 (12.6%) |
| Event | Mothers Corifollitropin Alfa 150 µg | Mothers recFSH 200 IU | Fetuses/Infants Corifollitropin Alfa 150 µg | Fetuses/Infants recFSH 200 IU |
|---|---|---|---|---|
| Premature babyPregnancy, puerperium and perinatal conditions | 0/274 | 0/267 | 56/352 | 48/326 |
| Premature labourPregnancy, puerperium and perinatal conditions | 37/274 | 33/267 | 0/352 | 0/326 |
| Breech presentationPregnancy, puerperium and perinatal conditions | 26/274 | 23/267 | 0/352 | 0/326 |
| Twin pregnancyPregnancy, puerperium and perinatal conditions | 16/274 | 15/267 | 0/352 | 0/326 |
| Arrested labourPregnancy, puerperium and perinatal conditions | 12/274 | 15/267 | 0/352 | 0/326 |
| Foetal distress syndromePregnancy, puerperium and perinatal conditions | 6/274 | 13/267 | 1/352 | 2/326 |
| Pre-eclampsiaPregnancy, puerperium and perinatal conditions | 12/274 | 10/267 | 0/352 | 0/326 |
| Threatened labourPregnancy, puerperium and perinatal conditions | 10/274 | 11/267 | 0/352 | 0/326 |
| Neonatal respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 0/274 | 0/267 | 13/352 | 12/326 |
| Atrial septal defectCongenital, familial and genetic disorders | 0/274 | 0/267 | 5/352 | 11/326 |
| Event | Mothers Corifollitropin Alfa 150 µg | Mothers recFSH 200 IU | Fetuses/Infants Corifollitropin Alfa 150 µg | Fetuses/Infants recFSH 200 IU |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 34/274 | 27/267 | 0/352 | 2/326 |
| HeadacheNervous system disorders | 24/274 | 31/267 | 0/352 | 0/326 |
| DyspepsiaGastrointestinal disorders | 27/274 | 22/267 | 0/352 | 0/326 |
| Back painMusculoskeletal and connective tissue disorders | 25/274 | 20/267 | 0/352 | 0/326 |
| ConstipationGastrointestinal disorders | 15/274 | 22/267 | 2/352 | 8/326 |
| Oedema PeripheralGeneral disorders | 21/274 | 13/267 | 0/352 | 0/326 |
| AnaemiaBlood and lymphatic system disorders | 20/274 | 17/267 | 0/352 | 0/326 |
| VomitingGastrointestinal disorders | 20/274 | 14/267 | 0/352 | 3/326 |
| Antepartum haemorrhagePregnancy, puerperium and perinatal conditions | 19/274 | 14/267 | 0/352 | 0/326 |
| Threatened labourPregnancy, puerperium and perinatal conditions | 18/274 | 15/267 | 0/352 | 0/326 |
Eligible mothers from the Base Trial P05787 (NCT00696800) who enrolled in Follow Up Trial P05712
| Age, Continuous(Years) | Mothers Corifollitropin Alfa 150 µg | Mothers recFSH 200 IU | Total |
|---|---|---|---|
| Mean | 31.4 ± 3.2 | 31.3 ± 3.5 | 31.3 ± 3.3 |
| Sex: Female, Male(Participants) | Mothers Corifollitropin Alfa 150 µg | Mothers recFSH 200 IU | Total |
|---|---|---|---|
| Female | 274 | 267 | 541 |
| Male | 0 | 0 | 0 |
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Organon and Co