Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells

Infertility Clinical Trial

Official title:

The Effect of Intrauterine Injection of Human Chorionic Gonadotrophins (hCG) on the Endometrial T-regulatory Cells and the Electronmicroscopic Endometrial Characteristics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064219
• Other study ID #: hCG and Treg cells
• Status: Completed
• Phase: N/A
• First received: February 5, 2010
• Last updated: November 2, 2013
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• 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

Intrauterine injection of hCG around the time of implantation may increase endometrial Treg cells and improve implantation. It has been demonstrated that regulatory T cells expand during pregnancy. hCG was found to be secreted by the embryo immediately after fertilization and has chemoattractant properties to Treg cells.

Description:

Aim of the work:

To study the effect of intrauterine injection of human chorionic gonadotrophin on the endometrial T regulatory cells (Treg cells)and the electromicroscopic endometrial characteristics.

Background:

It has been demonstrated that regulatory T cells expand during pregnancy and are present at the feto-maternal interface at very early stages in pregnancy.

Rational:

Intrauterine injection of hCG around the time of implantation may increase endometrial Treg cells and improve implantation.

Methods:

Intrauterine injection of 100 IU hCG will be done followed by endometrial biopsy to check for Treg cells and pinopodes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

Inclusion Criteria:

• Male factor infertility

• Ovulatory factor infertility

• Unexplained infertility

• Female age less than 39

Exclusion Criteria:

• Azoospermia

• Tubal factor infertility

• Pelvic endometriosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• human chorionic gonadotrophin
intrauterine injection of 100 IU hCG followed by endometrial biopsy .

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
The Egyptian IVF-ET Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the presence of Treg cells and pinopodes in the endometrium		4 weeks	No
Secondary	pregnancy rate		4 weeks	No

External Links

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