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Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer in Women With Previous IVF Failure

Primary Purpose

Infertility, Invitro Fertilization

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Human Chorionic Gonadotropin (HCG)

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, Invitro fertilization

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

- women with previous IVF failure undergoing fresh IVF cycle

Exclusion Criteria:

women with hydrosalpinges women with intrauterine lesion like submucous fibroid or polyps

Sites / Locations

Mansoura University Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

women undergoing IVF treatment will be subjected for intrauterine injection of 10 IU of human chorionic gonadotropin (HCG) (diluted in 0.025ml of tissue culture), 10 minutes before embryo transfer procedure.

women undergoing IVF treatment will embryo transfer procedure performed in the standard way without intrauterine injection of HCG.

Outcomes

Primary Outcome Measures

Live Birth

Secondary Outcome Measures

Full Information

NCT ID

NCT02329197

First Posted

December 26, 2014

Last Updated

December 30, 2014

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT02329197

Brief Title

Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer in Women With Previous IVF Failure

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

October 2015 (Anticipated)

Study Completion Date

March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Women with history of previous IVF cycle failure will be subjected to a fresh IVF cycle. At the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer catheter 10 minutes before embryo transfer procedure.

Detailed Description

Infertile women with history of previous IVF cycle failure will be subjected top a fresh IVF cycle. Following controlled ovarian hyperstimulation, ovum pick up and at the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer catheter 10 minutes before embryo transfer procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Invitro Fertilization

Keywords

Infertility, Invitro fertilization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Arm Title

Group B

Arm Type

No Intervention

Arm Description

women undergoing IVF treatment will embryo transfer procedure performed in the standard way without intrauterine injection of HCG.

Intervention Type

Drug

Intervention Name(s)

Human Chorionic Gonadotropin (HCG)

Other Intervention Name(s)

u-hCG

Intervention Description

intrauterine injection of HCG prior to embryo transfer in an IVF cycle

Primary Outcome Measure Information:

Title

Live Birth

Time Frame

9 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - women with previous IVF failure undergoing fresh IVF cycle Exclusion Criteria: women with hydrosalpinges women with intrauterine lesion like submucous fibroid or polyps

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed Gibreel, MD

Phone

002/01004045733

ahmedfathgi@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Gibreel, MD

Organizational Affiliation

Mansoura University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mansoura University Teaching Hospital

City

Mansoura

ZIP/Postal Code

53111

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed Gibreel, MD

12. IPD Sharing Statement

Learn more about this trial

Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer in Women With Previous IVF Failure

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