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Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility

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ClinicalTrials.gov Identifier: NCT03461601
Recruitment Status : Completed
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Walid Anwar Murad, Benha University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 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 : June 1, 2014
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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




Primary Outcome Measures :
  1. Live birth [ Time Frame: 10 months of randomization ]
    Defined as pregnancies maintained beyond 20 weeks of gestation


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Ahmed Walid Anwar Murad, Assistant Professor, Department of Obstetrics and Gynecology, Faculty of Medicine; Banha University, Benha University
ClinicalTrials.gov Identifier: NCT03461601     History of Changes
Other Study ID Numbers: 18144
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infertility
Flushing
Genital Diseases, Male
Genital Diseases, Female
Skin Manifestations
Signs and Symptoms
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs