Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 11:35 PM
Study NCT ID:
NCT01030393
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2009-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer
Sponsor:
The Egyptian IVF-ET Center
Organization:
Study Overview
Official Title:
Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chorionic gonadotrophins (hCG) play an important role in implantation. The aim of the study is to evaluate the effect of intrauterine injection of hCG before embryo transfer in IVF/ICSI on the implantation and pregnancy rates. The rational is that intrauterine hCG injection will attract regulatory T cells and improve implantation.
Detailed Description:
Background :
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: