Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility

NCT03461601 | Completed DMC

• 1 other identifier: 18144
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Unexplained Infertility

Outcome Measures

Primary Outcomes (1)

• Live birth

  Defined as pregnancies maintained beyond 20 weeks of gestation

  10 months of randomization

Secondary Outcomes (3)

• Chemical pregnancy

  One month after randomization

• Clinical pregnancy

  Two months after randomization

• Adverse effects

  one hour of the procedure

Study Arms (2)

HCG uterine flushing group

ACTIVE COMPARATOR

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; Procedure: IUI

IUI alone group

PLACEBO COMPARATOR

Intrauterine insemination alone plus vaginal flushing with 10 ml normal saline

Procedure: IUI; Procedure: Vaginal flushing with 10 ml normal saline

Interventions

HCG Uterine flushing PROCEDURE

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

HCG uterine flushing group

IUI PROCEDURE

Intrauterine insemination (IUI)

HCG uterine flushing group; IUI alone group

Vaginal flushing with 10 ml normal saline PROCEDURE

Flushing of the vagina with 10 ml of saline

IUI alone group

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Unexplained infertility (UI)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahmed Walid Anwar Murad: lead

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Vaginal flushing with 10 ml saline was performed in the control group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Obstetrics and Gynecology, Faculty of Medicine; Banha University

Model Details: intrauterine injection of human chorionic gonadotropin before intrauterine insemination (IUI) compared to IUI alone

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 12, 2018
• Study Start: June 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 12, 2018

Record last verified: 2018-03