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hCG Supplementation in Frozen-Thawed Embryo Transfer Cycle

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398229
First Posted: November 10, 2006
Last Update Posted: January 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
  • pregnancy rate [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Arik Tzukert, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT00398229     History of Changes
Other Study ID Numbers: freezehcg-HMO-CTIL
First Submitted: November 9, 2006
First Posted: November 10, 2006
Last Update Posted: January 1, 2009
Last Verified: November 2007

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