Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer

August 18, 2012 updated by: Ragaa Mansour, The Egyptian IVF-ET Center

Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI

Chorionic gonadotrophins (hCG) play an important role in implantation. The aim of the study is to evaluate the effect of intrauterine injection of hCG before embryo transfer in IVF/ICSI on the implantation and pregnancy rates. The rational is that intrauterine hCG injection will attract regulatory T cells and improve implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background :

Human chorionic gonadotrophin ( hCG) was found to secreted immediately after fertilization by the embryo. It plays an important role in implantation and in attracting regulatory T cells to the endometrium.

Rational :

Intrauterine injection of hCG before embryo transfer in IVF/ICSI may increase endometrial regulatory T cells ( Treg ) and improve the implantation and pregnancy rates.

Aim of the work :

To study the effect of intrauterine injection of hCG before embryo transfer on the implantation and pregnancy rates after IVF/ICSI.

Subjects :

Infertile patients undergoing ICSI.

Inclusion criteria :

  • Female age less than 40 years
  • Male factor infertility
  • Normal female hormonal profile and uterine cavity

Exclusion criteria :

  • Previous ICSI failure
  • Azoospermia
  • Endometriosis

Study group: Intrauterine injection of 100 iu of hCG (group 1)or 200 iu of hCG ( group 2) will be done during the dummy embryo transfer which is done 10-15 minutes before the actual embryo transfer.

Control group: The embryo transfer will be done without prior intrauterine injection of hCG

Main outcome measures :

Implantation and pregnancy rates

Secondary outcome measures :

miscarriage and delivery rates

Study Type

Interventional

Enrollment (Actual)

472

Phase

  • Phase 4

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

  • Egypt
      • Cairo, Egypt, 11431
        • The Egyptian IVF- ET 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

20 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • male factor infertility
  • normal female hormonal profile
  • normal uterine cavity

Exclusion Criteria:

  • previous ICSI failure
  • endometriosis
  • azoospermia

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intrauterine hCG

Experimental arm : intrauterine injection of 100 iu(group1)or 200 iu (group2) of hCG before embryo transfer.

Intrauterine injection of 500 iu hCG before embryo transfer
Drug: human chorionic gonadotrophin
intrauterine injection of 100 iu (group1) or 200 iu (group2) of hCG before embryo transfer in IVF/ICSI And intrauterine injection of 500 iu hCG before embryo transfer .
Other Names:
  • choriomon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
implantation and pregnancy rates
Time Frame: 5 weeks after embryo transfer
5 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Time Frame
miscarriage and delivery rates
Time Frame: 9 months from embryo transfer
9 months from embryo transfer

Collaborators and Investigators

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

Sponsor

The Egyptian IVF-ET Center

Investigators

  • Principal Investigator: Ragaa T Mansour, MD,PhD, The Egyptian IVF-ET Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

December 10, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimate)

December 11, 2009

Study Record Updates

Last Update Posted (Estimate)

August 21, 2012

Last Update Submitted That Met QC Criteria

August 18, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hCG 100

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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