Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 107012 (Care Program)(COMPLETED)(P05710)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702624
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 107012 for the Development of 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 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Mothers Experiencing Serious AEs (SAEs) [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Infants Experiencing AEs [ Time Frame: Up to 16 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Infants Experiencing SAEs [ Time Frame: Up to 16 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 113
Study Start Date: April 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Org 36286 100 μg
Single subcutaneous dose of Org 36286 150 μg
Drug: Org 36286
Single-dose Org 36286 150 μg
Other Name: corifollitropin alfa
recFSH 150 IU
recFSH administered subcutaneously at a daily dose of 150 IU
Drug: recFSH
Daily recFSH 150 IU
Other Names:
  • follitropin beta
  • Puregon®
  • Follistim®

Detailed Description:

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with Org 36286 or recFSH and became pregnant during Trial 107012. 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 embryo transfer in Trial 107012 were enrolled in this trial.

Criteria

Inclusion Criteria:

  • Participants who participated in trial 107012 and received at least one dose of either Org 36286 or Puregon®/Follistim® AQ Cartridge in trial 107012;
  • Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 107012;
  • 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: NCT00702624     History of Changes
Other Study ID Numbers: 107014, P05710
Study First Received: June 18, 2008
Last Updated: July 17, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Spain: Ministry of Health and Consumption
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products 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 July 28, 2014