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Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility

Primary Purpose

Unexplained Infertility

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HCG Uterine flushing
IUI
Vaginal flushing with 10 ml normal saline
Sponsored by
Ahmed Walid Anwar Murad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unexplained Infertility

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    HCG uterine flushing group

    IUI alone group

    Arm Description

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

    Intrauterine insemination alone plus vaginal flushing with 10 ml normal saline

    Outcomes

    Primary Outcome Measures

    Live birth
    Defined as pregnancies maintained beyond 20 weeks of gestation

    Secondary Outcome Measures

    Chemical pregnancy
    Defined as positive serum pregnancy test
    Clinical pregnancy
    Defined by the presence of gestational sac with fetal heartbeats on ultrasound scan or histological identification of trophoblastic tissue.
    Adverse effects
    Nausea, vomiting, and pain

    Full Information

    First Posted
    February 28, 2018
    Last Updated
    March 5, 2018
    Sponsor
    Ahmed Walid Anwar Murad
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03461601
    Brief Title
    Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2014 (Actual)
    Primary Completion Date
    June 1, 2017 (Actual)
    Study Completion Date
    June 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ahmed Walid Anwar Murad

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unexplained Infertility

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    intrauterine injection of human chorionic gonadotropin before intrauterine insemination (IUI) compared to IUI alone
    Masking
    Participant
    Masking Description
    Vaginal flushing with 10 ml saline was performed in the control group
    Allocation
    Randomized
    Enrollment
    210 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HCG uterine flushing group
    Arm Type
    Active Comparator
    Arm Description
    Uterine flushing was done one day before Intrauterine insemination (IUI) with HCG (500 IU) in 10 ml of saline followed by Intrauterine insemination (IUI).
    Arm Title
    IUI alone group
    Arm Type
    Placebo Comparator
    Arm Description
    Intrauterine insemination alone plus vaginal flushing with 10 ml normal saline
    Intervention Type
    Procedure
    Intervention Name(s)
    HCG Uterine flushing
    Intervention Description
    HCG Uterine flushing was done one day before IUI with HCG (500 IU) in 10 ml of saline.
    Intervention Type
    Procedure
    Intervention Name(s)
    IUI
    Intervention Description
    Intrauterine insemination (IUI)
    Intervention Type
    Procedure
    Intervention Name(s)
    Vaginal flushing with 10 ml normal saline
    Intervention Description
    Flushing of the vagina with 10 ml of saline
    Primary Outcome Measure Information:
    Title
    Live birth
    Description
    Defined as pregnancies maintained beyond 20 weeks of gestation
    Time Frame
    10 months of randomization
    Secondary Outcome Measure Information:
    Title
    Chemical pregnancy
    Description
    Defined as positive serum pregnancy test
    Time Frame
    One month after randomization
    Title
    Clinical pregnancy
    Description
    Defined by the presence of gestational sac with fetal heartbeats on ultrasound scan or histological identification of trophoblastic tissue.
    Time Frame
    Two months after randomization
    Title
    Adverse effects
    Description
    Nausea, vomiting, and pain
    Time Frame
    one hour of the procedure

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    37 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility

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