hCG Supplementation in Frozen-Thawed Embryo Transfer Cycle

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00398229
First received: November 9, 2006
Last updated: December 31, 2008
Last verified: November 2007
  Purpose

The implantation rate after frozen-thawed embryo transfer cycles depends mostly on the receptivity of the endometrium and the embryo quality.The effects of human chorionic gonadotropins (hCG) on the endometrium have been investigated for several years. hCG was shown to up-regulate gene expression during the differentiation of human endometrial stromal cells into decidua. The aim of our study was to assess the benefit of hCG supplementation throughout the secretory phase of artificial frozen-thawed embryo transfer cycles.


Condition Intervention Phase
Fertility Agents, Female
Drug: s.c. human chorionic gonadotropin (Ovitrelle)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Benefit of Human Chorionic Gonadotropin (hCG) Supplementation Throughout the Secretory Phase of Frozen-Thawed Embryo Transfer Cycles

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • implantation rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • pregnancy rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: November 2006
Study Completion Date: May 2008
Arms Assigned Interventions
Active Comparator: A
receiving hCG injection
Drug: s.c. human chorionic gonadotropin (Ovitrelle)
S.C. Ovitrelle 250 mcg once
Placebo Comparator: B Drug: s.c. human chorionic gonadotropin (Ovitrelle)
S.C. Ovitrelle 250 mcg once

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all women on frozen-thawed embryo-transfer cycle

Exclusion Criteria:

  • any allergy to injection of human chorionic gonadotropin before
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00398229

Locations
Israel
Hadassah Medical center
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Assaf Ben-Meir, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Arik Tzukert, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT00398229     History of Changes
Other Study ID Numbers: freezehcg-HMO-CTIL
Study First Received: November 9, 2006
Last Updated: December 31, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
In-Vitro Fertilization
human chorionic gonadotropin
frozen-thawed embryo transfer
implantation rate

Additional relevant MeSH terms:
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014