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Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Clomiphene Citrate 50mg
Cabergoline Oral Tablet
Placebo Oral Tablet
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • unexplained infertility, Primary or secondary.
  • Absence of galactorrhoea.
  • Normal serum prolactin.
  • Normal hysterosalpingography.
  • Normal spermogram.

Exclusion Criteria:

  • Women on other line of treatment as aromatase inhibitors,gonadotrophins, or tamoxifen.
  • Known hypersensitivity for cabergoline or clomiphene citrate.
  • Other factors of infertility as tubal factor, uterine factor or male factor.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    study group

    control group

    Arm Description

    will receive a dose of Clomiphene citrate 50 mg tablet , 1 tab twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package) first three months then Clomiphene citrate 50 mg tablet , 2 tabs twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package)

    will receive a dose of Clomiphene citrate and placebo tablets with same dose and duration

    Outcomes

    Primary Outcome Measures

    The number of mature follicles
    the follicles reach the size of 18 mm

    Secondary Outcome Measures

    Full Information

    First Posted
    May 26, 2018
    Last Updated
    May 26, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03549741
    Brief Title
    Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility
    Official Title
    Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2018 (Anticipated)
    Primary Completion Date
    June 2019 (Anticipated)
    Study Completion Date
    November 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Infertility refers to an inability to conceive after having regular unprotected sex. Infertility can also refer to the biological inability of an individual to contribute to conception, or to a female who cannot carry a pregnancy to full term. In many countries infertility refers to a couple that has failed to conceive after 12 months of regular sexual intercourse

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm Description
    will receive a dose of Clomiphene citrate 50 mg tablet , 1 tab twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package) first three months then Clomiphene citrate 50 mg tablet , 2 tabs twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package)
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    will receive a dose of Clomiphene citrate and placebo tablets with same dose and duration
    Intervention Type
    Drug
    Intervention Name(s)
    Clomiphene Citrate 50mg
    Intervention Description
    oral tablets
    Intervention Type
    Drug
    Intervention Name(s)
    Cabergoline Oral Tablet
    Intervention Description
    oral tablets
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Oral Tablet
    Intervention Description
    oral tablets
    Primary Outcome Measure Information:
    Title
    The number of mature follicles
    Description
    the follicles reach the size of 18 mm
    Time Frame
    14 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: unexplained infertility, Primary or secondary. Absence of galactorrhoea. Normal serum prolactin. Normal hysterosalpingography. Normal spermogram. Exclusion Criteria: Women on other line of treatment as aromatase inhibitors,gonadotrophins, or tamoxifen. Known hypersensitivity for cabergoline or clomiphene citrate. Other factors of infertility as tubal factor, uterine factor or male factor.

    12. IPD Sharing Statement

    Learn more about this trial

    Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility

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