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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702520
First received: June 18, 2008
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Pregnancy
Neonates
Drug: Org 36286

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38833 for Org 36286 (Corifollitropin Alfa)

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 49
Study Start Date: April 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Org 36286 150 ug
Org 36286 administered as a single subcutaneous dose of 150 ug
Drug: Org 36286
Subcutaneous Org 36286 at a dose of 100 ug or 150 ug
Other Name: corifollitropin alfa
Org 36286 100 ug
Org 36286 administered as a single subcutaneous dose of 100 ug
Drug: Org 36286
Subcutaneous Org 36286 at a dose of 100 ug or 150 ug
Other Name: corifollitropin alfa

Detailed Description:

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 during Trial 38833. For this trial, no study specific assessments are required, but information as obtained in standard practice will be 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
Study Population

Women with an ongoing pregnancy at least 10 weeks after ET in trial 38833 were enrolled in this trial.

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00702520     History of Changes
Other Study ID Numbers: 38834, P05783
Study First Received: June 18, 2008
Last Updated: July 17, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Merck Sharp & Dohme Corp.:
Neonatal outcome
Congenital malformations
In-Vitro fertilization
Controlled ovarian stimulation
Follow-up

ClinicalTrials.gov processed this record on April 16, 2014