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Completed

NCT Number: NCT03461601

Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility

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.

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Key information

Conditions

Unexplained Infertility

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HCG Uterine flushing

Procedure

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

IUI

Procedure

Intrauterine insemination (IUI)

Vaginal flushing with 10 ml normal saline

Procedure

Flushing of the vagina with 10 ml of saline

Primary outcomes

  1. Live birth

    Time frame: 10 months of randomization

    Defined as pregnancies maintained beyond 20 weeks of gestation

Secondary outcomes

  1. Chemical pregnancy

    Time frame: One month after randomization

    Defined as positive serum pregnancy test

  2. 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.

  3. Adverse effects

    Time frame: one hour of the procedure

    Nausea, vomiting, and pain

Sponsors and collaborators

Lead sponsor

Ahmed Walid Anwar Murad

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 12, 2018
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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