Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer
1 other identifier
interventional
472
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2009
CompletedFirst Posted
Study publicly available on registry
December 11, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedAugust 21, 2012
August 1, 2012
1 year
December 10, 2009
August 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
implantation and pregnancy rates
5 weeks after embryo transfer
Secondary Outcomes (1)
miscarriage and delivery rates
9 months from embryo transfer
Study Arms (1)
intrauterine hCG
EXPERIMENTALExperimental 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
Interventions
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 .
Eligibility Criteria
You may qualify if:
- male factor infertility
- normal female hormonal profile
- normal uterine cavity
You may not qualify if:
- previous ICSI failure
- endometriosis
- azoospermia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Egyptian IVF- ET center
Cairo, 11431, Egypt
Related Publications (2)
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.
PMID: 19380797BACKGROUNDMansour 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.
PMID: 22047664DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ragaa T Mansour, MD,PhD
The Egyptian IVF-ET Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
December 10, 2009
First Posted
December 11, 2009
Study Start
January 1, 2010
Primary Completion
January 1, 2011
Study Completion
February 1, 2011
Last Updated
August 21, 2012
Record last verified: 2012-08