Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ragaa Mansour, The Egyptian IVF-ET Center
ClinicalTrials.gov Identifier:
NCT01064219
First received: February 5, 2010
Last updated: November 2, 2013
Last verified: December 2010
  Purpose

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.


Condition Intervention
Infertility
Drug: human chorionic gonadotrophin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Effect of Intrauterine Injection of Human Chorionic Gonadotrophins (hCG) on the Endometrial T-regulatory Cells and the Electronmicroscopic Endometrial Characteristics

Resource links provided by NLM:


Further study details as provided by The Egyptian IVF-ET Center:

Primary Outcome Measures:
  • the presence of Treg cells and pinopodes in the endometrium [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intrauterine hCG
intrauterine injection of 100 hCG followed by endometrial biopsy
Drug: human chorionic gonadotrophin
intrauterine injection of 100 IU hCG followed by endometrial biopsy .
Other Name: choriomon

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Azoospermia
  • Tubal factor infertility
  • Pelvic endometriosis
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01064219

Locations
Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
The Egyptian IVF-ET Center
Investigators
Principal Investigator: Ragaa Mansour, MD,PhD The Egyptian IVF-ET Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ragaa Mansour, Director, the Egyptian IVF-ET Center, The Egyptian IVF-ET Center
ClinicalTrials.gov Identifier: NCT01064219     History of Changes
Other Study ID Numbers: hCG and Treg cells
Study First Received: February 5, 2010
Last Updated: November 2, 2013
Health Authority: Egypt: Ministry of Health, Drug Policy and Planning Center

Keywords provided by The Egyptian IVF-ET Center:
hCG
Treg cells
implantation
pinopodes
endometrium

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014