Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells
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ClinicalTrials.gov Identifier: NCT01064219 |
Recruitment Status
:
Completed
First Posted
: February 8, 2010
Last Update Posted
: November 5, 2013
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Tracking Information | ||||
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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 |
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 |
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. |
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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 |
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Condition ICMJE | Infertility | |||
Intervention ICMJE | Drug: human chorionic gonadotrophin
intrauterine injection of 100 IU hCG followed by endometrial biopsy .
Other Name: choriomon |
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Study Arms | Experimental: intrauterine hCG
intrauterine injection of 100 hCG followed by endometrial biopsy
Intervention: Drug: human chorionic gonadotrophin |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |