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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ragaa Mansour, The Egyptian IVF-ET Center
ClinicalTrials.gov Identifier:
NCT01030393
First received: December 10, 2009
Last updated: August 18, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: human chorionic gonadotrophin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI

Resource links provided by NLM:


Further study details as provided by The Egyptian IVF-ET Center:

Primary Outcome Measures:
  • implantation and pregnancy rates [ Time Frame: 5 weeks after embryo transfer ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • miscarriage and delivery rates [ Time Frame: 9 months from embryo transfer ] [ Designated as safety issue: Yes ]

Enrollment: 472
Study Start Date: January 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

Ages Eligible for Study:   20 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • previous ICSI failure
  • endometriosis
  • azoospermia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030393

Locations
Egypt
The Egyptian IVF- ET center
Cairo, Egypt, 11431
Sponsors and Collaborators
The Egyptian IVF-ET Center
Investigators
Principal Investigator: Ragaa T Mansour, MD,PhD The Egyptian IVF-ET Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ragaa Mansour, Director, The Egyptian IVF-ET Center
ClinicalTrials.gov Identifier: NCT01030393     History of Changes
Other Study ID Numbers: hCG 100
Study First Received: December 10, 2009
Last Updated: August 18, 2012
Health Authority: Egypt: Ministry of Health, Drug Policy and Planning Center

Keywords provided by The Egyptian IVF-ET Center:
hCG
pregnancy
implantation
ICSI
IVF

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Chorionic Gonadotropin
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014