Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells
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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 |
- the presence of Treg cells and pinopodes in the endometrium [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- pregnancy rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated 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 |
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
More Information
Additional Information:
No publications provided
| Responsible Party: | Ragaa Mansour, Director, 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: | December 28, 2010 |
| 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 Adenoma Genital Diseases, Male Genital Diseases, Female Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Chorionic Gonadotropin Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013