Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (Care Program)(Study 38834)(COMPLETED)(P05783)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00702520
• Date of registration: 18/06/2008
• Primary sponsor: Schering-Plough
• Public title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (Care Program)(Study 38834)(COMPLETED)(P05783) Care
• Scientific title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38833 for Org 36286 (Corifollitropin Alfa)
• Date of first enrolment: April 2006
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00702520
• Study type: Observational
• Study design: Time Perspective: Prospective

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects who received one dose of Org 36286 in Trial 38833;

- Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in
Trial 38833;

- Able and willing to give written informed consent.

Exclusion Criteria:

- None



Age minimum: 18 Years
Age maximum: 39 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Neonates

Pregnancy

Intervention(s)

Drug: Org 36286

Primary Outcome(s)

Prenatal diagnosis; Mode of delivery; Neonatal outcome; Safety assessment subjects/mothers and newborns/infants; Major/minor congenital malformations [Time Frame: One Year]

Secondary ID(s)

38834

P05783

Source(s) of Monetary Support

Please refer to primary and secondary sponsors