PregnancyNCT00702195
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)
An observational study of Pregnancy, run by Organon and Co.
Trial summary
The objective of this trial was to evaluate whether Org 36286 treatment in any Phase IIa clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment programs was safe for pregnant subjects and their offspring. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Org 36286 (corifollitropin alfa) and recFSH
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2002to 15 Sep 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All women who became pregnant during Trials 38805 or 38807 were enrolled in Trial 38817
Who may be able to join
- Subjects taking part in any clinical development trial of Org 36286 for OI or COH for IVF in Phase IIa;
- Ongoing pregnancy confirmed by ultrasonography (USS) at or beyond 12 weeks of gestation;
- 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 During Phase II Clinical Trials for the Development of Org 36286 (Corifollitropin Alfa).
The objective of this trial was to evaluate whether Org 36286 treatment in any Phase IIa clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment programs was safe for pregnant subjects and their offspring. Data from subjects who participated in Trials 38805 and 38807 and became pregnant were evaluated.
Read the detailed description
This was an open prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during any Phase IIa clinical trial of Org 36286 for OI or COH for IVF. For this trial, no study specific assessments were required, but information obtained in standard practice was used.
- Conditions
- Pregnancy
- Being tested
- Org 36286 (corifollitropin alfa), Placebo, recFSH
- Keywords
- Neonatal outcome, Congenital malformations, In-Vitro Fertilization, Controlled ovarian stimulation, Follow-up, Ovulation Induction, Neonates
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Org 36286 (corifollitropin alfa)Drug
Also called corifollitropin alfa
single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807
PlaceboDrug
single dose of placebo (administered under protocol 38805)
recFSHDrug
Also called follitropin beta, Puregon®, Follistim®
150 IU recFSH daily (reference group administered under protocol 38807)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | all doses of Org 36286 (corifollitropin alfa) from trial 38805 (7.5 μg, 15 μg, 30 μg and 60 μg) Receives: Drug: Org 36286 (corifollitropin alfa) | |
| Experimental Group 2 | Placebo Receives: Drug: Placebo | |
| Experimental Group 3 | all doses of Org 36286 (corifollitropin alfa) from trial 38807 (120 μg, 180 μg and 240 μg) Receives: Drug: Org 36286 (corifollitropin alfa) | |
| Experimental Group 4 | 150 IU Puregon® Receives: Drug: recFSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy status at 20 weeks of gestation; Take-home baby rate
Measured: one pregnancy period
Secondary outcomes (1)
Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities
Measured: one pregnancy period
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 start1 Jan 2002
- Primary completion15 Sep 2003
- Study completion15 Sep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 29 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
- NCT00702195
- Sponsor's protocol ID
- P06054
- Other IDs
- 38817
- Status last verified
- Feb 2022
- First submitted
- 18 Jun 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- 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 15 Aug 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 During Phase II Clinical Trials for the Development of Org 36286 (Corifollitropin Alfa).
- ClinicalTrials.gov ID
- NCT00702195
- Acronym / sponsor ID
- P06054
- Conditions
- Pregnancy
- Keywords
- Neonatal outcome, Congenital malformations, In-Vitro Fertilization, Controlled ovarian stimulation, Follow-up, Ovulation Induction, Neonates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 15 Sep 2003 (actual)
- Study completion
- 15 Sep 2003 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Not posted in the source record
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 trial was to evaluate whether Org 36286 treatment in any Phase IIa clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment programs was safe for pregnant subjects and their offspring. Data from subjects who participated in Trials 38805 and 38807 and became pregnant were evaluated.
Detailed description
This was an open prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during any Phase IIa clinical trial of Org 36286 for OI or COH for IVF. For this trial, no study specific assessments were required, but information obtained in standard practice was used.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | – | Drug: Org 36286 (corifollitropin alfa)all doses of Org 36286 (corifollitropin alfa) from trial 38805 (7.5 μg, 15 μg, 30 μg and 60 μg) |
| Experimental Group 2 | – | Drug: PlaceboPlacebo |
| Experimental Group 3 | – | Drug: Org 36286 (corifollitropin alfa)all doses of Org 36286 (corifollitropin alfa) from trial 38807 (120 μg, 180 μg and 240 μg) |
| Experimental Group 4 | – | Drug: recFSH150 IU Puregon® |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All women who became pregnant during Trials 38805 or 38807 were enrolled in Trial 38817
Key inclusion criteria (3 listed)
- Subjects taking part in any clinical development trial of Org 36286 for OI or COH for IVF in Phase IIa;
- Ongoing pregnancy confirmed by ultrasonography (USS) at or beyond 12 weeks of gestation;
- 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 |
|---|---|---|
| Org 36286 (corifollitropin alfa)Also: corifollitropin alfasingle dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807 | Drug | Experimental Group 1, Experimental Group 3 |
| Placebosingle dose of placebo (administered under protocol 38805) | Drug | Experimental Group 2 |
| recFSHAlso: follitropin beta, Puregon®, Follistim®150 IU recFSH daily (reference group administered under protocol 38807) | Drug | Experimental Group 4 |
Primary outcome
Pregnancy status at 20 weeks of gestation; Take-home baby rate
Time frame: one pregnancy period
1 secondary outcome
Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities
Time frame: one pregnancy period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- 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, 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 15 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pregnancy status at 20 weeks of gestation; Take-home baby rate (time frame: one pregnancy period). 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 NCT00702195, 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 15 Aug 2024.