Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI|
- implantation and pregnancy rates [ Time Frame: 5 weeks after embryo transfer ] [ Designated as safety issue: Yes ]
- miscarriage and delivery rates [ Time Frame: 9 months from embryo transfer ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Study Completion Date:||February 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030393
|The Egyptian IVF- ET center|
|Cairo, Egypt, 11431|
|Principal Investigator:||Ragaa T Mansour, MD,PhD||The Egyptian IVF-ET Center|