PregnancyCareNCT00702338
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713)
An observational study of Pregnancy and Neonates, run by Organon and Co.
Trial summary
The objective of follow-up study P05713 is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of monofollicular growth in women who underwent ovulation induction (OI) in base study P05693 (NCT00697255) is safe for pregnant participants and their offspring. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- What is being tested?
- corifollitropin alfa, recombinant Follicle Stimulating Hormone (recFSH) and human Chorion Gonadotropin (hCG)
- Type of treatment
- Injection or infusion
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2008to 15 Dec 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 39 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with an ongoing pregnancy at least 10 weeks after bolus injection of hCG in base study P05693 (NCT00697255).
Who may be able to join
- Participants who participated in base study P05693 (NCT00697255) and received at least one dose of corifollitropin alfa
- Ongoing pregnancy confirmed by ultrasound at least 10 weeks after bolus injection of hCG in base study P05693
- Able and willing to give written informed consent (informed consent is
- incorporated in the informed consent form of protocol P05693)
Who cannot join
- None
About this study
Official title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Ovulation Induction in Clinical Trial 107010 for the Development of Org 36286 (Corifollitropin Alfa)
The objective of follow-up study P05713 is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of monofollicular growth in women who underwent ovulation induction (OI) in base study P05693 (NCT00697255) is safe for pregnant participants and their offspring.
Read the detailed description
Base study P05693 (NCT00697255) was planned to include two separate stages (Ia+Ib and II).
Stage Ia was open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose recombinant Follicle Stimulating Hormone (recFSH) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.
Stage Ib was open-label and uncontrolled in a small cohort of women (n=3) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose Human Chorion Gonadotropin (hCG) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.
Stage II was planned to be open-label and randomized (n=40) to evaluate whether the intended dosing regimen of corifollitropin alfa followed by low dose recFSH (n=20) or hCG (n=20) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.
P05713 is a follow-up (FU) study to prospectively monitor pregnancy, delivery, and neonatal outcome of women who became ongoing pregnant during base study P05693 (NCT00697255). For this trial, no study specific assessments will be required and no treatment will be administered, but information as obtained in standard practice will be used. Enrollment will begin when the first ongoing pregnancy resulting from the base study has been established (ultrasound ≥ 10 weeks after bolus injection of hCG).
- Being tested
- corifollitropin alfa, recombinant Follicle Stimulating Hormone (recFSH), human Chorion Gonadotropin (hCG), hCG Bolus injection
- Keywords
- Neonatal outcome, Congenital malformations, Ovulation Induction, 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 Org 36286, MK-8962, SCH 900962
SC injection(s) of corifollitropin alfa (30 mcg) was administered the first, second or third day after onset of progestagen-induced withdrawal bleeding in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.
recombinant Follicle Stimulating Hormone (recFSH)Biological
Daily injections of SC recFSH (50 IU/75 IU) were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.
human Chorion Gonadotropin (hCG)Biological
Daily injections of SC hCG injection were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.
hCG Bolus injectionBiological
Bolus injection of SC hCG was administered in base study P05693 (NCT00697255) to induce final oocyte maturation if at least one follicle was ≥18 mm and no more than two follicles ≥15 mm were observed. No treatment was administered on the current follow-up study.
| Study group | Role | What they receive |
|---|---|---|
| corifollitropin alfa + recFSH Mothers | Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered). Receives: Drug: corifollitropin alfa; Biological: recombinant Follicle Stimulating Hormone (recFSH); Biological: hCG Bolus injection | |
| corifollitropin alfa + hCG Mothers | Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered). Receives: Drug: corifollitropin alfa; Biological: human Chorion Gonadotropin (hCG); Biological: hCG Bolus injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined
The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants treated in base study P05693.
Measured: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)
Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis
Take-Home Baby Rate was alternately defined ad hoc as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants who received bolus injection of hCG in the base study.
Measured: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)
Number of Mothers With Adverse Events (AEs) During Follow-up
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 ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)
Number of Mothers With Serious AEs (SAEs) During Follow-up
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 ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)
Number of Infants With AEs During Follow-up
An AE is 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: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study
Number of Infants With SAEs During Follow-up
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Measured: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study
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 start15 May 2008
- Primary completion9 Aug 2008
- Study completion15 Dec 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702338
- Sponsor's protocol ID
- P05713
- Other IDs
- 2006-000967-26, 107011, MK-8962-006
- Acronym
- Care
- Status last verified
- Feb 2022
- First submitted
- 18 Jun 2008
- Last updated
- 5 Sep 2024
- 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 5 Sep 2024. 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 Ovulation Induction in Clinical Trial 107010 for the Development of Org 36286 (Corifollitropin Alfa)
- ClinicalTrials.gov ID
- NCT00702338
- Acronym / sponsor ID
- Care / P05713
- Keywords
- Neonatal outcome, Congenital malformations, Ovulation Induction, Follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 15 May 2008 (actual)
- Primary completion
- 9 Aug 2008 (actual)
- Study completion
- 15 Dec 2008 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Posted 5 Jun 2014
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 follow-up study P05713 is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of monofollicular growth in women who underwent ovulation induction (OI) in base study P05693 (NCT00697255) is safe for pregnant participants and their offspring.
Detailed description
Base study P05693 (NCT00697255) was planned to include two separate stages (Ia+Ib and II).
Stage Ia was open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose recombinant Follicle Stimulating Hormone (recFSH) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.
Stage Ib was open-label and uncontrolled in a small cohort of women (n=3) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose Human Chorion Gonadotropin (hCG) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.
Stage II was planned to be open-label and randomized (n=40) to evaluate whether the intended dosing regimen of corifollitropin alfa followed by low dose recFSH (n=20) or hCG (n=20) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.
P05713 is a follow-up (FU) study to prospectively monitor pregnancy, delivery, and neonatal outcome of women who became ongoing pregnant during base study P05693 (NCT00697255). For this trial, no study specific assessments will be required and no treatment will be administered, but information as obtained in standard practice will be used. Enrollment will begin when the first ongoing pregnancy resulting from the base study has been established (ultrasound ≥ 10 weeks after bolus injection of hCG).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| corifollitropin alfa + recFSH Mothers | – | Drug: corifollitropin alfa, Biological: recombinant Follicle Stimulating Hormone (recFSH), Biological: hCG Bolus injectionEligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered). |
| corifollitropin alfa + hCG Mothers | – | Drug: corifollitropin alfa, Biological: human Chorion Gonadotropin (hCG), Biological: hCG Bolus injectionEligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered). |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with an ongoing pregnancy at least 10 weeks after bolus injection of hCG in base study P05693 (NCT00697255).
Key inclusion criteria (4 listed)
- Participants who participated in base study P05693 (NCT00697255) and received at least one dose of corifollitropin alfa
- Ongoing pregnancy confirmed by ultrasound at least 10 weeks after bolus injection of hCG in base study P05693
- Able and willing to give written informed consent (informed consent is
- incorporated in the informed consent form of protocol P05693)
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: Org 36286, MK-8962, SCH 900962SC injection(s) of corifollitropin alfa (30 mcg) was administered the first, second or third day after onset of progestagen-induced withdrawal bleeding in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study. | Drug | corifollitropin alfa + hCG Mothers, corifollitropin alfa + recFSH Mothers |
| recombinant Follicle Stimulating Hormone (recFSH)Daily injections of SC recFSH (50 IU/75 IU) were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study. | Biological | corifollitropin alfa + recFSH Mothers |
| human Chorion Gonadotropin (hCG)Daily injections of SC hCG injection were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study. | Biological | corifollitropin alfa + hCG Mothers |
| hCG Bolus injectionBolus injection of SC hCG was administered in base study P05693 (NCT00697255) to induce final oocyte maturation if at least one follicle was ≥18 mm and no more than two follicles ≥15 mm were observed. No treatment was administered on the current follow-up study. | Biological | corifollitropin alfa + hCG Mothers, corifollitropin alfa + recFSH Mothers |
Primary outcome
Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined
Time frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)
The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants treated in base study P05693.
Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis
Time frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)
Take-Home Baby Rate was alternately defined ad hoc as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants who received bolus injection of hCG in the base study.
Number of Mothers With Adverse Events (AEs) During Follow-up
Time frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)
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 Mothers With Serious AEs (SAEs) During Follow-up
Time frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)
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 With AEs During Follow-up
Time frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study
An AE is 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 With SAEs During Follow-up
Time frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is 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 5 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 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 5 Sep 2024. 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 5 Jun 2014). 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 Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined (time frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)). The study lists 6 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 NCT00702338, 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 5 Sep 2024.