Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38819 (Care Program) (COMPLETED)(P05712)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00703014
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
Drug: recFSH

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 38819 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 16 Weeks Following Delivery ] [ Designated as safety issue: Yes ]
  • Number of Mothers Experiencing Serious AEs (SAEs) [ Time Frame: Up to 16 Weeks Following Delivery ] [ Designated as safety issue: Yes ]
  • Number of Infants Experiencing AEs [ Time Frame: Up to 16 Weeks Following Delivery ] [ Designated as safety issue: Yes ]
  • Number of Infants Experiencing SAEs [ Time Frame: Up to 16 Weeks Following Delivery ] [ Designated as safety issue: Yes ]

Enrollment: 541
Study Start Date: October 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Org 36286 150 ug
Single subcutaneous dose of Org 36286 150 ug
Drug: Org 36286
Org 36286 150 ug
Other Name: Corifollitropin alfa
recFSH 200 IU
Daily subcutaneous dose of recFSH 200 IU
Drug: recFSH
recFSH 200 IU
Other Names:
  • follitropin beta
  • Puregon®
  • Follistim®

Detailed Description:

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of all women who were treated with Org 36286 or recFSH and became pregnant during Trial 38819. 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 36 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 38819 were enrolled in this trial.

Criteria

Inclusion Criteria:

  • Participants who received at least one dose of either Org 36286 or

Puregon®/Follistim® AQ Cartridge in Trial 38819;

  • Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 38819;
  • Able and willing to give written informed consent.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: NCT00703014     History of Changes
Other Study ID Numbers: 38821, 2004-004772-36, P05712
Study First Received: June 18, 2008
Last Updated: July 17, 2013
Health Authority: United States: Food and Drug Administration

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 July 24, 2014