Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility

Sponsor

Ahmed Walid Anwar Murad (Other)

Overall Status

Completed

CT.gov ID

NCT03461601

Collaborator

(none)

210

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Unexplained Infertility	Procedure: HCG Uterine flushing Procedure: IUI Procedure: Vaginal flushing with 10 ml normal saline	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

intrauterine injection of human chorionic gonadotropin before intrauterine insemination (IUI) compared to IUI aloneintrauterine injection of human chorionic gonadotropin before intrauterine insemination (IUI) compared to IUI alone

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Live birth [10 months of randomization]
Defined as pregnancies maintained beyond 20 weeks of gestation

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 37 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ahmed Walid Anwar Murad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Walid Anwar Murad, Assistant Professor, Department of Obstetrics and Gynecology, Faculty of Medicine; Banha University, Benha University

ClinicalTrials.gov Identifier:

NCT03461601

Other Study ID Numbers:

18144

First Posted:

Mar 12, 2018

Last Update Posted:

Mar 12, 2018

Last Verified:

Mar 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Infertility

Flushing

Study Results

No Results Posted as of Mar 12, 2018