Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01030393|
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : August 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: human chorionic gonadotrophin||Phase 4|
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.
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.
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
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||472 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||February 2011|
Experimental: 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
Drug: 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 Name: choriomon
- implantation and pregnancy rates [ Time Frame: 5 weeks after embryo transfer ]
- miscarriage and delivery rates [ Time Frame: 9 months from embryo transfer ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030393
|The Egyptian IVF- ET center|
|Cairo, Egypt, 11431|
|Principal Investigator:||Ragaa T Mansour, MD,PhD||The Egyptian IVF-ET Center|