Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility

NCT ID: NCT03461601

Last Updated: 2018-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-01

Study Completion Date

2017-06-01

Brief Summary

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A prospective randomized study included 210 women with Unexplained infertility subjected to combined ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before IUI and control group subjected to IUI alone.

Detailed Description

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A prospective randomized study included 210 patients with Unexplained infertility subjected to coupled ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before IUI and control group subjected to IUI alone.

Conditions

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Unexplained Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

intrauterine injection of human chorionic gonadotropin before intrauterine insemination (IUI) compared to IUI alone
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Vaginal flushing with 10 ml saline was performed in the control group

Study Groups

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HCG uterine flushing group

Uterine flushing was done one day before Intrauterine insemination (IUI) with HCG (500 IU) in 10 ml of saline followed by Intrauterine insemination (IUI).

Group Type ACTIVE_COMPARATOR

HCG Uterine flushing

Intervention Type PROCEDURE

HCG Uterine flushing was done one day before IUI with HCG (500 IU) in 10 ml of saline.

IUI

Intervention Type PROCEDURE

Intrauterine insemination (IUI)

IUI alone group

Intrauterine insemination alone plus vaginal flushing with 10 ml normal saline

Group Type PLACEBO_COMPARATOR

IUI

Intervention Type PROCEDURE

Intrauterine insemination (IUI)

Vaginal flushing with 10 ml normal saline

Intervention Type PROCEDURE

Flushing of the vagina with 10 ml of saline

Interventions

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HCG Uterine flushing

HCG Uterine flushing was done one day before IUI with HCG (500 IU) in 10 ml of saline.

Intervention Type PROCEDURE

IUI

Intrauterine insemination (IUI)

Intervention Type PROCEDURE

Vaginal flushing with 10 ml normal saline

Flushing of the vagina with 10 ml of saline

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Unexplained infertility (UI)

Exclusion Criteria

* body mass index (BMI) ≥35 kg/m2,
* Follicle Stimulating Hormone \>10 International Unit /Litter in early follicular phase,
* diagnosed cause of infertility, menstrual cycle irregularity,
* ovarian cysts,
* sever cervical stenosis,
* former IUI,
* ongoing pregnancy and
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ahmed Walid Anwar Murad

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Walid Anwar Murad

Assistant Professor, Department of Obstetrics and Gynecology, Faculty of Medicine; Banha University

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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18144

Identifier Type: -

Identifier Source: org_study_id

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