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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

February 5, 2010
November 2, 2013
February 2010
December 2010   (final data collection date for primary outcome measure)
the presence of Treg cells and pinopodes in the endometrium [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01064219 on ClinicalTrials.gov Archive Site
pregnancy rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells
The Effect of Intrauterine Injection of Human Chorionic Gonadotrophins (hCG) on the Endometrial T-regulatory Cells and the Electronmicroscopic Endometrial Characteristics

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Infertility
Drug: human chorionic gonadotrophin
intrauterine injection of 100 IU hCG followed by endometrial biopsy .
Other Name: choriomon
Experimental: intrauterine hCG
intrauterine injection of 100 hCG followed by endometrial biopsy
Intervention: Drug: human chorionic gonadotrophin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Azoospermia
  • Tubal factor infertility
  • Pelvic endometriosis
Female
20 Years to 38 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01064219
hCG and Treg cells
No
Ragaa Mansour, The Egyptian IVF-ET Center
The Egyptian IVF-ET Center
Not Provided
Principal Investigator: Ragaa Mansour, MD,PhD The Egyptian IVF-ET Center
The Egyptian IVF-ET Center
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP