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Follow-up Protocol on the Outcome of Frozen-Thawed Embryo Transfer Cycles From Clinical Trial 107012 (Complete)(Study 107015)(COMPLETED)(P05711)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702546
First received: June 18, 2008
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET) cycles performed after the embryos are cryopreserved in Trial 107012 in order to estimate the cumulative pregnancy rate for each treatment group.


Condition Intervention
In Vitro Fertilization
Drug: corifollitropin alfa
Drug: recFSH (follitropin alfa)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 107012

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

Primary Outcome Measures:
  • The primary efficacy parameter is the cumulative ongoing pregnancy rate. [ Time Frame: After one or more Frozen-Thawed embryo transfer cycles following cryopreservation. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number and percentage of subjects with a miscarriage, ectopic pregnancy, clinical pregnancy, vital pregnancy and ongoing pregnancy will be calculated per 107012 treatment group and subsequent FTET cycle (i.e. FTET cycle 1, FTET cycle 2, etc). [ Time Frame: After one or more Frozen-Thawed embryo transfer cycles following cryopreservation. ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: March 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Experimental group (Org 36286 (corifollitropin alfa))
Drug: corifollitropin alfa
Single injection of 100 μg Org 36286 administered under protocol 107012
Other Name: Org 36286
Group 2
Reference group (recFSH (follitropin alfa))
Drug: recFSH (follitropin alfa)
Daily recFSH administered under protocol 107012
Other Name: Puregon®/Follistim®

Detailed Description:

This is a follow-up protocol to collect the outcome of frozen-thawed embryo transfer cycles, performed after the embryos are cryopreserved in Trial 107012, to enable estimation of the cumulative pregnancy rate for each treatment group.

  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 from whom embryos have been cryopreserved in Trial 107012

Criteria

Inclusion Criteria:

  • Subjects from whom embryos have been cryopreserved in Trial 107012 of which at least one embryo is thawed for use in a subsequent FTET cycle;
  • 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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00702546     History of Changes
Other Study ID Numbers: P05711, EudraCT #: 2006-003813-42;, 107015
Study First Received: June 18, 2008
Last Updated: October 23, 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
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health

Keywords provided by Merck Sharp & Dohme Corp.:
In-vitro fertilization
Controlled Ovarian Stimulation
Cumulative pregnancy data
Follow-up

Additional relevant MeSH terms:
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014