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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):

Study Description
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.

Condition or disease Intervention/treatment Phase
Infertility Drug: human chorionic gonadotrophin Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI
Study Start Date : January 2010
Primary Completion Date : January 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. implantation and pregnancy rates [ Time Frame: 5 weeks after embryo transfer ]

Secondary Outcome Measures :
  1. miscarriage and delivery rates [ Time Frame: 9 months from embryo transfer ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: August 21, 2012
Last Verified: August 2012

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

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