Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells
This study has been completed.
Sponsor:
The Egyptian IVF-ET Center
Information provided by (Responsible Party):
Ragaa Mansour, The Egyptian IVF-ET Center
ClinicalTrials.gov Identifier:
NCT01064219
First received: February 5, 2010
Last updated: November 2, 2013
Last verified: December 2010
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | February 5, 2010 | |||
| Last Updated Date | November 2, 2013 | |||
| Start Date ICMJE | February 2010 | |||
| 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 ] [ Designated as safety issue: No ] | |||
| 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 ] [ Designated as safety issue: No ] | |||
| 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 Provided | |||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 Arm (s) | Experimental: intrauterine hCG
intrauterine injection of 100 hCG followed by endometrial biopsy
Intervention: Drug: human chorionic gonadotrophin |
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| Publications * | Not Provided | |||
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* 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 | |||
| Enrollment ICMJE | 20 | |||
| Completion Date | December 2010 | |||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | 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 | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | 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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| Information Provided By | The Egyptian IVF-ET Center | |||
| Verification Date | December 2010 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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