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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030393
• Other study ID #: hCG 100
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2009
• Last updated: August 18, 2012
• Start date: January 2010
• Est. completion date: February 2011

Study information

• Verified date: August 2012
• Source: The Egyptian IVF-ET Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health, Drug Policy and Planning Center
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

• male factor infertility

• normal female hormonal profile

• normal uterine cavity

Exclusion Criteria:

• previous ICSI failure

• endometriosis

• azoospermia

Study Design

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

Related Conditions & MeSH terms

• Infertility

Intervention

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 .

Locations

Country	Name	City	State
Egypt	The Egyptian IVF- ET center	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
The Egyptian IVF-ET Center

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implantation and pregnancy rates		5 weeks after embryo transfer	Yes
Secondary	miscarriage and delivery rates		9 months from embryo transfer	Yes

External Links

•   springerLink-Journal Article