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Trial record 17 of 422 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer

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ClinicalTrials.gov Identifier: NCT01030393
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : August 21, 2012
Sponsor:
Information provided by (Responsible Party):
Ragaa Mansour, The Egyptian IVF-ET Center

Tracking Information
First Submitted Date  ICMJE December 10, 2009
First Posted Date  ICMJE December 11, 2009
Last Update Posted Date August 21, 2012
Study Start Date  ICMJE January 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2009)
implantation and pregnancy rates [ Time Frame: 5 weeks after embryo transfer ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01030393 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2009)
miscarriage and delivery rates [ Time Frame: 9 months from embryo transfer ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer
Official Title  ICMJE Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE 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
Study Arms  ICMJE 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

Intervention: Drug: human chorionic gonadotrophin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2012)
472
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2009)
900
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • previous ICSI failure
  • endometriosis
  • azoospermia
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01030393
Other Study ID Numbers  ICMJE hCG 100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ragaa Mansour, The Egyptian IVF-ET Center
Study Sponsor  ICMJE The Egyptian IVF-ET Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ragaa T Mansour, MD,PhD The Egyptian IVF-ET Center
PRS Account The Egyptian IVF-ET Center
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP