Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility

Not Applicable

Completed

• Conditions: Unexplained Infertility
• Interventions: Procedure: HCG Uterine flushing; Procedure: IUI; Procedure: Vaginal flushing with 10 ml normal saline

• Registration Number: NCT03461601
• Lead Sponsor: Ahmed Walid Anwar Murad

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.

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 Timeline

• Study Start: 2014-06-01
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-01
• Study First Submitted: 2018-02-28
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-05
• Last Update Submitted: 2018-03-05
• Study First Posted: 2018-03-12
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCG uterine flushing group	IUI	Uterine flushing was done one day before Intrauterine insemination (IUI) with HCG (500 IU) in 10 ml of saline followed by Intrauterine insemination (IUI).
IUI alone group	IUI	Intrauterine insemination alone plus vaginal flushing with 10 ml normal saline
HCG uterine flushing group	HCG Uterine flushing	Uterine flushing was done one day before Intrauterine insemination (IUI) with HCG (500 IU) in 10 ml of saline followed by Intrauterine insemination (IUI).
IUI alone group	Vaginal flushing with 10 ml normal saline	Intrauterine insemination alone plus vaginal flushing with 10 ml normal saline

Primary Outcome Measures

Name	Time	Method
Live birth	10 months of randomization	Defined as pregnancies maintained beyond 20 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
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