PregnancyCareNCT00702624
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)
An observational study of Pregnancy and Neonates, run by Organon and Co.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- What is being tested?
- Corifollitropin alfa, recFSH (follitropin beta) and gonadatropin releasing hormone (GnRH) antagonist ganirelix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Jun 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with an ongoing pregnancy at least 10 weeks after embryo transfer in base study P05690 (NCT00702845) were enrolled in this trial.
Who may be able to join
- Participants who participated in base study P05690 (NCT00702845) and received at least one dose of either corifollitropin alfa (Org 36286) or recFSH in base study P05690;
- Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in base study P05690;
- Able and willing to give written informed consent.
Who cannot join
- None
About this study
Official title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 107012 for the Development of Org 36286 (Corifollitropin Alfa)
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.
Read the detailed description
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with corifollitropin alfa or recFSH and became pregnant during the base study P05690 (NCT00702845). For this trial no study specific assessments are required, but information as obtained in standard practice will be used.
- Being tested
- Corifollitropin alfa, recFSH (follitropin beta), gonadatropin releasing hormone (GnRH) antagonist ganirelix, human chorion gonadotropin (hCG), progesterone
- Keywords
- Neonatal outcome, Congenital malformations, In-Vitro fertilization, Controlled ovarian stimulation, Follow-up
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corifollitropin alfaDrug
Also called SCH 900962, MK-8962
Single injection of 100 μg corifollitropin alfa administered under protocol P05690
recFSH (follitropin beta)Biological
Also called follitropin beta, Puregon®, Follistim®
Daily recFSH administered under protocol P05690
gonadatropin releasing hormone (GnRH) antagonist ganirelixDrug
GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690
human chorion gonadotropin (hCG)Biological
hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690
progesteroneBiological
Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.
placebo-recFSH (follitropin beta)Drug
Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690
placebo-corifollitropin alfaDrug
Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690
open-label recFSH (follitropin beta)Biological
Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Corifollitropin alfa; Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix; Biological: human chorion gonadotropin (hCG); Biological: progesterone; Drug: placebo-recFSH (follitropin beta); Biological: open-label recFSH (follitropin beta) | |
| 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. Receives: Biological: recFSH (follitropin beta); Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix; Biological: human chorion gonadotropin (hCG); Biological: progesterone; Drug: placebo-corifollitropin alfa; Biological: open-label recFSH (follitropin beta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)
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.
Measured: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)
Number of Expectant Mothers Experiencing Adverse Events (AEs)
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.
Measured: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)
Number of Expectant Mothers Experiencing Serious AEs (SAEs)
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.
Measured: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)
Number of Infants Experiencing AEs
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.
Measured: Up to 12 weeks after birth
Number of Infants Experiencing SAEs
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.
Measured: Up to 12 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startApr 2007
- Primary completionApr 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702624
- Sponsor's protocol ID
- P05710
- Other IDs
- 2006-003812-23, 107014, MK-8962-003
- Acronym
- Care
- Status last verified
- Feb 2022
- First submitted
- 18 Jun 2008
- Last updated
- 3 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15.
PubMed 22587997
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 107012 for the Development of Org 36286 (Corifollitropin Alfa)
- ClinicalTrials.gov ID
- NCT00702624
- Acronym / sponsor ID
- Care / P05710
- Keywords
- Neonatal outcome, Congenital malformations, In-Vitro fertilization, Controlled ovarian stimulation, Follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Posted 30 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with corifollitropin alfa or recFSH and became pregnant during the base study P05690 (NCT00702845). For this trial no study specific assessments are required, but information as obtained in standard practice will be used.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corifollitropin alfa 100 μg | – | Drug: Corifollitropin alfa, Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix, Biological: human chorion gonadotropin (hCG), Biological: progesterone, Drug: placebo-recFSH (follitropin beta), Biological: open-label recFSH (follitropin beta)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. |
| recFSH 150 IU | – | Biological: recFSH (follitropin beta), Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix, Biological: human chorion gonadotropin (hCG), Biological: progesterone, Drug: placebo-corifollitropin alfa, Biological: open-label recFSH (follitropin beta)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. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with an ongoing pregnancy at least 10 weeks after embryo transfer in base study P05690 (NCT00702845) were enrolled in this trial.
Key inclusion criteria (3 listed)
- Participants who participated in base study P05690 (NCT00702845) and received at least one dose of either corifollitropin alfa (Org 36286) or recFSH in base study P05690;
- Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in base study P05690;
- Able and willing to give written informed consent.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corifollitropin alfaAlso: SCH 900962, MK-8962Single injection of 100 μg corifollitropin alfa administered under protocol P05690 | Drug | Corifollitropin alfa 100 μg |
| recFSH (follitropin beta)Also: follitropin beta, Puregon®, Follistim®Daily recFSH administered under protocol P05690 | Biological | recFSH 150 IU |
| gonadatropin releasing hormone (GnRH) antagonist ganirelixGnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690 | Drug | Corifollitropin alfa 100 μg, recFSH 150 IU |
| human chorion gonadotropin (hCG)hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690 | Biological | Corifollitropin alfa 100 μg, recFSH 150 IU |
| progesteroneUnder protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM. | Biological | Corifollitropin alfa 100 μg, recFSH 150 IU |
| placebo-recFSH (follitropin beta)Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690 | Drug | Corifollitropin alfa 100 μg |
| placebo-corifollitropin alfaSingle SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690 | Drug | recFSH 150 IU |
| open-label recFSH (follitropin beta)Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690 | Biological | Corifollitropin alfa 100 μg, recFSH 150 IU |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22587997Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Neonates, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00702624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.