Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702988
First received: June 18, 2008
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

The objective of this trial was to evaluate whether Org 36286 treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant subjects 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 During Clinical Trial 38826 for the Development of Org 36286 (Corifollitropin Alfa).

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

Primary Outcome Measures:
  • Pregnancy status at 20 weeks of gestation [ Time Frame: one pregnancy period ] [ Designated as safety issue: No ]
  • Take-home baby rate [ Time Frame: one pregnancy period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy follow-up [ Time Frame: one pregnancy period ] [ Designated as safety issue: Yes ]
  • Delivery follow-up [ Time Frame: one pregnancy period ] [ Designated as safety issue: Yes ]
  • Neonatal outcome [ Time Frame: one pregnancy period ] [ Designated as safety issue: Yes ]
  • Infant follow-up [ Time Frame: one pregnancy period ] [ Designated as safety issue: Yes ]
  • Congenital malformations and chromosomal abnormalities [ Time Frame: one pregnancy period ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: October 2003
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Experimental Group 1
all doses of Org 36286 (corifollitropin alfa) (60 μg, 120 μg and 180 μg)
Drug: Org 36286
single dose of 60, 120, or 180 μg Org 36286 (experimental group administered under protocol 38826)
Other Name: Corifollitropin alfa
Experimental Group 2
150 IU recFSH
Drug: recFSH
150 IU recFSH daily (reference group administered under protocol 38826)
Other Name: Follitropin Beta, Puregon®, Follistim®

Detailed Description:

This was an open, prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during Trial 38826. For this trial, no study specific assessments were required, but information 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
Study Population

Women with an ongoing pregnancy at least 10 weeks after embryo transfer in Trial 38826 were enrolled in this trial.

Criteria

Inclusion Criteria:

  • Subjects who participated in Trial 38826 and became pregnant (as confirmed by USS at or beyond 10 weeks after ET) after having received at least one dose of either Org 36286 or Puregon®; and
  • 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: NCT00702988     History of Changes
Other Study ID Numbers: P06056, 38827
Study First Received: June 18, 2008
Last Updated: May 30, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 October 02, 2014