Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility

March 5, 2018 updated by: Ahmed Walid Anwar Murad

The Impact of Uterine Flushing With Human Chorionic Gonadotrophin Before Intrauterine Insemination on Pregnancy and Live Birth Rates in Women With Unexplained Infertility: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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
  • renal or hepatic diseases were all the exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Procedure: HCG Uterine flushing
HCG Uterine flushing was done one day before IUI with HCG (500 IU) in 10 ml of saline.
Procedure: IUI
Intrauterine insemination (IUI)
Placebo Comparator: IUI alone group
Intrauterine insemination alone plus vaginal flushing with 10 ml normal saline
Procedure: IUI
Intrauterine insemination (IUI)
Procedure: Vaginal flushing with 10 ml normal saline
Flushing of the vagina with 10 ml of saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth
Time Frame: 10 months of randomization
Defined as pregnancies maintained beyond 20 weeks of gestation
10 months of randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemical pregnancy
Time Frame: One month after randomization
Defined as positive serum pregnancy test
One month after randomization
Clinical pregnancy
Time Frame: Two months after randomization
Defined by the presence of gestational sac with fetal heartbeats on ultrasound scan or histological identification of trophoblastic tissue.
Two months after randomization
Adverse effects
Time Frame: one hour of the procedure
Nausea, vomiting, and pain
one hour of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed Walid Anwar Murad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 5, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18144

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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