hCG Supplementation in Frozen-Thawed Embryo Transfer Cycle

December 31, 2008 updated by: Hadassah Medical Organization

The Benefit of Human Chorionic Gonadotropin (hCG) Supplementation Throughout the Secretory Phase of Frozen-Thawed Embryo Transfer Cycles

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • all women on frozen-thawed embryo-transfer cycle

Exclusion Criteria:

  • any allergy to injection of human chorionic gonadotropin before

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B
Drug: s.c. human chorionic gonadotropin (Ovitrelle)
S.C. Ovitrelle 250 mcg once
Active Comparator: A
receiving hCG injection
Drug: s.c. human chorionic gonadotropin (Ovitrelle)
S.C. Ovitrelle 250 mcg once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
implantation rate
Time Frame: 4 weeks
4 weeks
pregnancy rate
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Assaf Ben-Meir, MD, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

November 9, 2006

First Submitted That Met QC Criteria

November 9, 2006

First Posted (Estimate)

November 10, 2006

Study Record Updates

Last Update Posted (Estimate)

January 1, 2009

Last Update Submitted That Met QC Criteria

December 31, 2008

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • freezehcg-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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