Intra-uterine Injection of Human Chorionic Gonadotrophin(hCG) Before Embryo Transfer
Information source: The Egyptian IVF-ET Center
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: human chorionic gonadotrophin (Drug)
Phase: Phase 4
Sponsored by: The Egyptian IVF-ET Center
Official(s) and/or principal investigator(s):
Ragaa T Mansour, MD,PhD, Principal Investigator, Affiliation: The Egyptian IVF-ET Center
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.
Official title: Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: implantation and pregnancy rates
Secondary outcome: 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.
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
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
Minimum age: 20 Years.
Maximum age: 39 Years.
- male factor infertility
- normal female hormonal profile
- normal uterine cavity
- previous ICSI failure
Locations and Contacts
The Egyptian IVF- ET center, Cairo 11431, Egypt; Recruiting
Ragaa Mansour, MD,PhD, Phone: 2012 212 2299, Email: firstname.lastname@example.org
Ragaa T Mansour, MD,PhD, Principal Investigator
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.
Starting date: January 2010
Last updated: January 14, 2010