Clinical trial NCT01030393: Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer
Official title: Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: hCG
pregnancy
implantation
ICSI
IVF
Lead sponsor: The Egyptian IVF-ET Center
Sponsor class: OTHER
First posted: 2009-12-11
Enrollment: 472
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* male factor infertility
* normal female hormonal profile
* normal uterine cavity

Exclusion Criteria:

* previous ICSI failure
* endometriosis
* azoospermia

Primary outcomes:
measure: implantation and pregnancy rates
timeFrame: 5 weeks after embryo transfer
Secondary outcomes:
measure: miscarriage and delivery rates
timeFrame: 9 months from embryo transfer
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The Egyptian IVF- ET center
Study officials:
affiliation: The Egyptian IVF-ET Center
name: Ragaa T Mansour, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.