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Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01064219
First Posted: February 8, 2010
Last Update Posted: November 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ragaa Mansour, The Egyptian IVF-ET Center
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Ragaa Mansour, The Egyptian IVF-ET Center:

Primary Outcome Measures:
  • the presence of Treg cells and pinopodes in the endometrium [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: February 5, 2010
First Posted: February 8, 2010
Last Update Posted: November 5, 2013
Last Verified: December 2010

Keywords provided by Ragaa Mansour, 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