Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility

Unexplained Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461601
• Other study ID #: 18144
• Status: Completed
• Phase: N/A
• First received: February 28, 2018
• Last updated: March 5, 2018
• Start date: June 1, 2014
• Est. completion date: June 1, 2017

Study information

• Verified date: March 2018
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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.

Related Conditions & MeSH terms

• Flushing
• Infertility
• Unexplained Infertility

Intervention

Procedure:
• HCG Uterine flushing
HCG Uterine flushing was done one day before IUI with HCG (500 IU) in 10 ml of saline.
• IUI
Intrauterine insemination (IUI)
• Vaginal flushing with 10 ml normal saline
Flushing of the vagina with 10 ml of saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Walid Anwar Murad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth	Defined as pregnancies maintained beyond 20 weeks of gestation	10 months of randomization
Secondary	Chemical pregnancy	Defined as positive serum pregnancy test	One month after randomization
Secondary	Clinical pregnancy	Defined by the presence of gestational sac with fetal heartbeats on ultrasound scan or histological identification of trophoblastic tissue.	Two months after randomization
Secondary	Adverse effects	Nausea, vomiting, and pain	one hour of the procedure