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Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
human chorionic gonadotrophin
Sponsored by
The Egyptian IVF-ET Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility focused on measuring hCG, Treg cells, implantation, pinopodes, endometrium

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Azoospermia
  • Tubal factor infertility
  • Pelvic endometriosis

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intrauterine hCG

Arm Description

intrauterine injection of 100 hCG followed by endometrial biopsy

Outcomes

Primary Outcome Measures

the presence of Treg cells and pinopodes in the endometrium

Secondary Outcome Measures

pregnancy rate

Full Information

First Posted
February 5, 2010
Last Updated
November 2, 2013
Sponsor
The Egyptian IVF-ET Center
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1. Study Identification

Unique Protocol Identification Number
NCT01064219
Brief Title
Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells
Official Title
The Effect of Intrauterine Injection of Human Chorionic Gonadotrophins (hCG) on the Endometrial T-regulatory Cells and the Electronmicroscopic Endometrial Characteristics
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Egyptian IVF-ET Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
hCG, Treg cells, implantation, pinopodes, endometrium

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intrauterine hCG
Arm Type
Experimental
Arm Description
intrauterine injection of 100 hCG followed by endometrial biopsy
Intervention Type
Drug
Intervention Name(s)
human chorionic gonadotrophin
Other Intervention Name(s)
choriomon
Intervention Description
intrauterine injection of 100 IU hCG followed by endometrial biopsy .
Primary Outcome Measure Information:
Title
the presence of Treg cells and pinopodes in the endometrium
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
pregnancy rate
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male factor infertility Ovulatory factor infertility Unexplained infertility Female age less than 39 Exclusion Criteria: Azoospermia Tubal factor infertility Pelvic endometriosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragaa Mansour, MD,PhD
Organizational Affiliation
The Egyptian IVF-ET Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Links:
URL
http://www.cu.edu.eg/english/
Description
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Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells

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