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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
human chorionic gonadotrophin
Sponsored by
The Egyptian IVF-ET Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring hCG, pregnancy, implantation, ICSI, IVF

Eligibility Criteria

20 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • previous ICSI failure
  • endometriosis
  • azoospermia

Sites / Locations

  • The Egyptian IVF- ET center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intrauterine hCG

Arm Description

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

Outcomes

Primary Outcome Measures

implantation and pregnancy rates

Secondary Outcome Measures

miscarriage and delivery rates

Full Information

First Posted
December 10, 2009
Last Updated
August 18, 2012
Sponsor
The Egyptian IVF-ET Center
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1. Study Identification

Unique Protocol Identification Number
NCT01030393
Brief Title
Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer
Official Title
Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Egyptian IVF-ET Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
hCG, pregnancy, implantation, ICSI, IVF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
472 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intrauterine hCG
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
human chorionic gonadotrophin
Other Intervention Name(s)
choriomon
Intervention Description
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 .
Primary Outcome Measure Information:
Title
implantation and pregnancy rates
Time Frame
5 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
miscarriage and delivery rates
Time Frame
9 months from embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male factor infertility normal female hormonal profile normal uterine cavity Exclusion Criteria: previous ICSI failure endometriosis azoospermia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragaa T Mansour, MD,PhD
Organizational Affiliation
The Egyptian IVF-ET Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Egyptian IVF- ET center
City
Cairo
ZIP/Postal Code
11431
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
19380797
Citation
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.
Results Reference
background
PubMed Identifier
22047664
Citation
Mansour 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.
Results Reference
derived

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

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