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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Infertility

Intervention / Treatment
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* Drug: human chorionic gonadotrophin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male factor infertility normal female hormonal profile normal uterine cavity Exclusion Criteria: previous ICSI failure endometriosis azoospermia

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intrauterine hCG<br>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<br>* 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 .<br>* Other names: choriomon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation and pregnancy rates |  | 5 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miscarriage and delivery rates |  | 9 months from embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, hCG, pregnancy, implantation, ICSI