Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38825 (Care Program)(P05715)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702234
First received: June 18, 2008
Last updated: July 15, 2013
Last verified: July 2013

June 18, 2008
July 15, 2013
August 2006
December 2009   (final data collection date for primary outcome measure)
  • Number of Mothers Experiencing Adverse Events (AEs) [ Time Frame: Up to 1 Year ] [ Designated as safety issue: Yes ]
  • Number of Mothers Experiencing Serious AEs (SAEs) [ Time Frame: Up to 1 Year ] [ Designated as safety issue: Yes ]
  • Number of Infants Experiencing AEs [ Time Frame: Up to 1 Year ] [ Designated as safety issue: Yes ]
  • Number of Infants Experiencing SAEs [ Time Frame: Up to 1 Year ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00702234 on ClinicalTrials.gov Archive Site
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Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38825 (Care Program)(P05715)(COMPLETED)
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38825 for Org 36286 (Corifollitropin Alfa)

The objective of this trial is to evaluate whether 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.

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of all women who were treated with Org 36286 and became pregnant after fresh embryo transfer during Trial 38825. For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.

Observational
Time Perspective: Prospective
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Non-Probability Sample

Women with an ongoing pregnancy at least 10 weeks after ET in trial 38825 were enrolled in this trial.

  • Pregnancy
  • Neonates
Drug: Org 36286
Org 36286 150 μg
Other Name: corifollitropin alfa
Org 32686 150 µg
Single subcutaneous dose of Org 36286 150 µg
Intervention: Drug: Org 36286
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants who received at least one dose of Org 36286 in Trial 38825;
  • Ongoing pregnancy confirmed by ultrasound at least 10 weeks after a fresh

embryo transfer in Trial 38825;

  • Able and willing to give written informed consent.

Exclusion Criteria:

  • None
Female
18 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00702234
38829, EudraCT #: 2004-004967-30;, P05715
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP