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

Information source: The Egyptian IVF-ET Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: human chorionic gonadotrophin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: The Egyptian IVF-ET Center

Official(s) and/or principal investigator(s):
Ragaa T Mansour, MD,PhD, Principal Investigator, Affiliation: The Egyptian IVF-ET Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: implantation and pregnancy rates

Secondary outcome: miscarriage and delivery rates

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

Eligibility

Minimum age: 20 Years. Maximum age: 39 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- male factor infertility

- normal female hormonal profile

- normal uterine cavity

Exclusion Criteria:

- previous ICSI failure

- endometriosis

- azoospermia

Locations and Contacts

The Egyptian IVF- ET center, Cairo 11431, Egypt
Additional Information

springerLink-Journal Article

Related publications:

Schumacher A, Brachwitz N, Sohr S, Engeland K, Langwisch S, Dolaptchieva M, Alexander T, Taran A, Malfertheiner SF, Costa SD, Zimmermann G, Nitschke C, Volk HD, Alexander H, Gunzer M, Zenclussen AC. Human chorionic gonadotropin attracts regulatory T cells into the fetal-maternal interface during early human pregnancy. J Immunol. 2009 May 1;182(9):5488-97. doi: 10.4049/jimmunol.0803177.

Starting date: January 2010
Last updated: August 18, 2012

Page last updated: August 23, 2015

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