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

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: human chorionic gonadotrophin

• Registration Number: NCT01030393
• Lead Sponsor: The Egyptian IVF-ET Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-11
• Study Start: 2010-01
• Primary Completion: 2011-01
• Study Completion: 2011-02
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-18
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 472

Inclusion Criteria

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

Exclusion Criteria

• previous ICSI failure
• endometriosis
• azoospermia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intrauterine hCG	human chorionic gonadotrophin	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

Primary Outcome Measures

Name	Time	Method
implantation and pregnancy rates	5 weeks after embryo transfer

Secondary Outcome Measures

Name	Time	Method
miscarriage and delivery rates	9 months from embryo transfer

Trial Locations

Locations (1)

The Egyptian IVF- ET center; 🇪🇬 Cairo, Egypt