Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells
Information source: The Egyptian IVF-ET Center
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: human chorionic gonadotrophin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: The Egyptian IVF-ET Center Official(s) and/or principal investigator(s):
Ragaa Mansour, MD,PhD, Principal Investigator, Affiliation: The Egyptian IVF-ET Center
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.
Clinical Details
Official title: The Effect of Intrauterine Injection of Human Chorionic Gonadotrophins (hCG) on the Endometrial T-regulatory Cells and the Electronmicroscopic Endometrial Characteristics
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic
Primary outcome: the presence of Treg cells and pinopodes in the endometrium
Secondary outcome: pregnancy rate
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
Minimum age: 20 Years.
Maximum age: 38 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Male factor infertility
- Ovulatory factor infertility
- Unexplained infertility
- Female age less than 39
Exclusion Criteria:
- Azoospermia
- Tubal factor infertility
- Pelvic endometriosis
Locations and Contacts
Cairo University, Cairo, Egypt; Recruiting
Ragaa T Mansour, MD,PhD, Phone: 2012 212 2299, Email: ragaa.mansour@gmail.com
Yahia El Faissal, MD, Sub-Investigator
Additional Information
Starting date: February 2010
Last updated: March 23, 2010
|
