Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells

Tracking Information
First Submitted Date ICMJE	February 5, 2010
First Posted Date ICMJE	February 8, 2010
Last Update Posted Date	November 5, 2013
Study Start Date ICMJE	February 2010
Actual Primary Completion Date	December 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 5, 2010)	the presence of Treg cells and pinopodes in the endometrium [ Time Frame: 4 weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01064219 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 5, 2010)	pregnancy rate [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells
Official Title ICMJE	The Effect of Intrauterine Injection of Human Chorionic Gonadotrophins (hCG) on the Endometrial T-regulatory Cells and the Electronmicroscopic Endometrial Characteristics
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Diagnostic
Condition ICMJE	Infertility
Intervention ICMJE	Drug: human chorionic gonadotrophin; intrauterine injection of 100 IU hCG followed by endometrial biopsy .; Other Name: choriomon
Study Arms	Experimental: intrauterine hCG; intrauterine injection of 100 hCG followed by endometrial biopsy; Intervention: Drug: human chorionic gonadotrophin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 5, 2010)	20
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2010
Actual Primary Completion Date	December 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Male factor infertility; Ovulatory factor infertility; Unexplained infertility; Female age less than 39 Exclusion Criteria: Azoospermia; Tubal factor infertility; Pelvic endometriosis
Sex/Gender	Sexes Eligible for Study: Female
Ages	20 Years to 38 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Egypt
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01064219
Other Study ID Numbers ICMJE	hCG and Treg cells
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Ragaa Mansour, The Egyptian IVF-ET Center
Study Sponsor ICMJE	The Egyptian IVF-ET Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Ragaa Mansour, MD,PhD The Egyptian IVF-ET Center
PRS Account	The Egyptian IVF-ET Center
Verification Date	December 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP