Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer
NCT ID: NCT01030393
Last Updated: 2012-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
472 participants
INTERVENTIONAL
2010-01-31
2011-02-28
Brief Summary
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Detailed Description
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Human chorionic gonadotrophin ( hCG) was found to secreted immediately after fertilization by the embryo. It plays an important role in implantation and in attracting regulatory T cells to the endometrium.
Rational :
Intrauterine injection of hCG before embryo transfer in IVF/ICSI may increase endometrial regulatory T cells ( Treg ) and improve the implantation and pregnancy rates.
Aim of the work :
To study the effect of intrauterine injection of hCG before embryo transfer on the implantation and pregnancy rates after IVF/ICSI.
Subjects :
Infertile patients undergoing ICSI.
Inclusion criteria :
* Female age less than 40 years
* Male factor infertility
* Normal female hormonal profile and uterine cavity
Exclusion criteria :
* Previous ICSI failure
* Azoospermia
* Endometriosis
Study group: Intrauterine injection of 100 iu of hCG (group 1)or 200 iu of hCG ( group 2) will be done during the dummy embryo transfer which is done 10-15 minutes before the actual embryo transfer.
Control group: The embryo transfer will be done without prior intrauterine injection of hCG
Main outcome measures :
Implantation and pregnancy rates
Secondary outcome measures :
miscarriage and delivery rates
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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intrauterine hCG
Experimental arm : intrauterine injection of 100 iu(group1)or 200 iu (group2) of hCG before embryo transfer.
Intrauterine injection of 500 iu hCG before embryo transfer
human chorionic gonadotrophin
intrauterine injection of 100 iu (group1) or 200 iu (group2) of hCG before embryo transfer in IVF/ICSI And intrauterine injection of 500 iu hCG before embryo transfer .
Interventions
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human chorionic gonadotrophin
intrauterine injection of 100 iu (group1) or 200 iu (group2) of hCG before embryo transfer in IVF/ICSI And intrauterine injection of 500 iu hCG before embryo transfer .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* normal female hormonal profile
* normal uterine cavity
Exclusion Criteria
* endometriosis
* azoospermia
20 Years
39 Years
FEMALE
No
Sponsors
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The Egyptian IVF-ET Center
OTHER
Responsible Party
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Ragaa Mansour
Director
Principal Investigators
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Ragaa T Mansour, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
The Egyptian IVF-ET Center
Locations
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The Egyptian IVF- ET center
Cairo, , Egypt
Countries
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References
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Schumacher A, Brachwitz N, Sohr S, Engeland K, Langwisch S, Dolaptchieva M, Alexander T, Taran A, Malfertheiner SF, Costa SD, Zimmermann G, Nitschke C, Volk HD, Alexander H, Gunzer M, Zenclussen AC. Human chorionic gonadotropin attracts regulatory T cells into the fetal-maternal interface during early human pregnancy. J Immunol. 2009 May 1;182(9):5488-97. doi: 10.4049/jimmunol.0803177.
Mansour R, Tawab N, Kamal O, El-Faissal Y, Serour A, Aboulghar M, Serour G. Intrauterine injection of human chorionic gonadotropin before embryo transfer significantly improves the implantation and pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection: a prospective randomized study. Fertil Steril. 2011 Dec;96(6):1370-1374.e1. doi: 10.1016/j.fertnstert.2011.09.044. Epub 2011 Nov 1.
Other Identifiers
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hCG 100
Identifier Type: -
Identifier Source: org_study_id