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

The Egyptian IVF-ET Center

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: human chorionic gonadotrophin

Study type: Interventional

Funder types: Other

Identifiers

NCT01030393

hCG 100

Details and patient eligibility

About

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.

Full 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

Enrollment: 472 patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• previous ICSI failure
• endometriosis
• azoospermia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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472 participants in 1 patient group

intrauterine hCG

Experimental group

Description:

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

Treatment:

Drug: human chorionic gonadotrophin