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NCT Number: NCT01030393

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The Egyptian IVF- ET center

Cairo, 11431, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • previous ICSI failure
  • endometriosis
  • azoospermia

Treatment and study plan

human chorionic gonadotrophin

Drug

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 names: choriomon

Primary outcomes

  1. implantation and pregnancy rates

    Time frame: 5 weeks after embryo transfer

Secondary outcomes

  1. miscarriage and delivery rates

    Time frame: 9 months from embryo transfer

Sponsors and collaborators

Lead sponsor

The Egyptian IVF-ET Center

Other

Registry information

Official study title

Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 11, 2009
Registry last updated
Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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