Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 107010 (Study 107011)(COMPLETED)(P05713) (Care)
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Purpose
The objective of this trial is to evaluate whether Org 36286 treatment for the induction of monofollicular growth in women undergoing ovulation induction (OI) is safe for pregnant subjects and their offspring.
| Condition | Intervention |
|---|---|
|
Pregnancy Neonates |
Drug: Org 36286 (corifollitropin alfa) and 200 IU hCG Drug: Org 36286 (corifollitropin alfa) and 50IU/75IU recFSH |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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). |
- Prenatal diagnosis; Mode of delivery; Neonatal outcome; Safety assessment subjects/mothers and newborns/infants; Major/minor congenital malformations [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
| Enrollment: | 1 |
| Study Start Date: | August 2006 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Trial 107010 Group 1
Org 36286 and 200 IU hCG
|
Drug: Org 36286 (corifollitropin alfa) and 200 IU hCG
Eligible subjects will receive a subcutaneous injection of Org 36286 (stage Ib/II: 30 ug) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient the subject will receive a second or third dose of Org 36286 (stage Ib/II: 20 ug). As soon as the largest follicle reaches a size of 12 mm the subject will start daily injections with hCG (stage Ib/II: 200 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is >= 18 mm and in total no more than two follicles >= 15 mm are observed.
Other Name: Corifollitropin alfa
|
|
Trial 107010 Group 2
Org 36286 and 50IU/75IU recFSH
|
Drug: Org 36286 (corifollitropin alfa) and 50IU/75IU recFSH
Eligible subjects will receive a subcutaneous injection of Org 36286 (stage Ia:15 ug) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient the subject will receive a second or third dose of Org 36286 (stage Ia: 15 ug). As soon as the largest follicle reaches a size of 12 mm the subject will start daily injections with FSH (stage Ia: 50 IU, stage II: 75 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is >= 18 mm and in total no more than two follicles >= 15 mm are observed.
|
Detailed Description:
Trial 107010 included 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 Org 36286 followed by daily low dose recFSH would provide an appropriate response in eligible subjects meeting all inclusion and none of the exclusion criteria.
Stage Ib was open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of Org 36286 followed by daily low dose hCG would provide an appropriate response in eligible subjects meeting all inclusion and none of the exclusion criteria.
Stage II was open-label and randomized (n=40) to evaluate whether the intended dosing regimen of Org 36286 followed by low dose FSH (n=20) or hCG (n=20)would provide an appropriate response in eligible subjects meeting all inclusion and none of the exclusion criteria.
This was a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who became ongoing pregnant during Trial 107010. For this trial, no study specific assessments were required, but information as obtained in standard practice was used.
Eligibility| Ages Eligible for Study: | 18 Years to 39 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Women with an ongoing pregnancy at least 10 weeks after bolus injection of hCG in trial 107010
Inclusion Criteria:
- Subjects who participated in trial 107010 and received at least one dose of Org 36286;
- Ongoing pregnancy confirmed by ultrasound at least 10 weeks after bolus injection of hCG in Trial 107010;
- Able and willing to give written informed consent (informed consent is incorporated in the informed consent form of protocol 107010).
Exclusion Criteria:
- None
Contacts and Locations More Information
No publications provided by Schering-Plough
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00702338 History of Changes |
| Other Study ID Numbers: | 107011, EudraCT #: 2006-000967-26, P05713 |
| Study First Received: | June 18, 2008 |
| Last Updated: | October 16, 2009 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Schering-Plough:
|
Neonatal outcome Congenital malformations Ovulation Induction Follow-up |
ClinicalTrials.gov processed this record on June 18, 2013