Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 38819 (Study 38831)(P05716) (Complete)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702273
First received: June 18, 2008
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved in Trial 38819, in order to estimate the cumulative pregnancy rate for each treatment group.


Condition Intervention
In Vitro Fertilization
Drug: corifollitropin alfa
Drug: follitropin beta

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 38819

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 38819 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 ]

Enrollment: 344
Study Start Date: September 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Experimental Group
Org 36286 (corifollitropin alfa)
Drug: corifollitropin alfa
150 µg Org 36286 (corifollitropin alfa)
Other Name: Org 36286
Reference Group
recFSH (follitropin alfa)
Drug: follitropin beta
200 IU recFSH (follitropin beta)
Other Names:
  • recFSH
  • Puregon/Follistim AQ Cartridge

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 38819, 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:   Probability Sample
Study Population

Women from whom embryos have been cryopreserved in Trial 38819

Criteria

Inclusion Criteria:

  • Subjects from whom embryos have been cryopreserved in Trial 38819 of which at least one embryo is thawed for use in a subsequent FTET cycle;
  • Able and willing to give 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: NCT00702273     History of Changes
Other Study ID Numbers: P05716, EudraCT #: 2004-004773-28;, 38831
Study First Received: June 18, 2008
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration

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
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014