Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells

NCT ID: NCT01064219

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility

Keywords

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hCG Treg cells implantation pinopodes endometrium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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intrauterine hCG

intrauterine injection of 100 hCG followed by endometrial biopsy

Group Type EXPERIMENTAL

human chorionic gonadotrophin

Intervention Type DRUG

intrauterine injection of 100 IU hCG followed by endometrial biopsy .

Interventions

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human chorionic gonadotrophin

intrauterine injection of 100 IU hCG followed by endometrial biopsy .

Intervention Type DRUG

Other Intervention Names

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choriomon

Eligibility Criteria

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Inclusion Criteria

* Male factor infertility
* Ovulatory factor infertility
* Unexplained infertility
* Female age less than 39

Exclusion Criteria

* Azoospermia
* Tubal factor infertility
* Pelvic endometriosis
Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Egyptian IVF-ET Center

OTHER

Sponsor Role lead

Responsible Party

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Ragaa Mansour

Director, the Egyptian IVF-ET Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ragaa Mansour, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Egyptian IVF-ET Center

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Related Links

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Other Identifiers

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hCG and Treg cells

Identifier Type: -

Identifier Source: org_study_id