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The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene

Primary Purpose

Anovulatory

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sildenafil & clomiphene citrate
clomiphene only
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anovulatory

Eligibility Criteria

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

Inclusion Criteria:

  • Women age 21-35 years.
  • Anovulatory cycles due to polycystic ovaries syndrome.
  • Non-smokers.
  • Free of major medical illness

Exclusion Criteria:

  • Women with myoma or adenomyosis
  • Women with congenital uterine anomaly.
  • Chronic use of any medications including non-steroidal anti-inflammatory drugs.
  • Associated cases of infertility other than PCOs (male factor, tubal factor,….).
  • Asherman syndrome.
  • Cases with endometrial hyperplasia.
  • Cases with endometrial polyp

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    (Sildenafil & clomiphene citrate group)

    clomiphene only

    Arm Description

    105 Patients will receive 25 mg sildenafil citrate 6 hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation

    105 patients will receive only clomiphene citrate 100mg/day (day 2 to 6) orally (2 tablets at same time daily).

    Outcomes

    Primary Outcome Measures

    Clinical pregnancy rate

    Secondary Outcome Measures

    endometrial thickness
    miscarriage rate
    ectopic pregnancy rate
    Side Effects of Vasodilators

    Full Information

    First Posted
    January 21, 2016
    Last Updated
    August 13, 2017
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02663830
    Brief Title
    The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene
    Official Title
    The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene: A Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 2016 (Actual)
    Primary Completion Date
    January 10, 2017 (Actual)
    Study Completion Date
    March 12, 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in women undergoing induction of ovulation using clomiphene citrate.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    210 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    (Sildenafil & clomiphene citrate group)
    Arm Type
    Experimental
    Arm Description
    105 Patients will receive 25 mg sildenafil citrate 6 hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation
    Arm Title
    clomiphene only
    Arm Type
    Active Comparator
    Arm Description
    105 patients will receive only clomiphene citrate 100mg/day (day 2 to 6) orally (2 tablets at same time daily).
    Intervention Type
    Drug
    Intervention Name(s)
    Sildenafil & clomiphene citrate
    Other Intervention Name(s)
    seldin and clomid
    Intervention Description
    105 Patients will receive 25 mg sildenafil citrate 6hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation
    Intervention Type
    Drug
    Intervention Name(s)
    clomiphene only
    Other Intervention Name(s)
    clomid
    Intervention Description
    105 Patients will receive clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation
    Primary Outcome Measure Information:
    Title
    Clinical pregnancy rate
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    endometrial thickness
    Time Frame
    2 weeks
    Title
    miscarriage rate
    Time Frame
    13 weeks
    Title
    ectopic pregnancy rate
    Time Frame
    8 weeks
    Title
    Side Effects of Vasodilators
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women age 21-35 years. Anovulatory cycles due to polycystic ovaries syndrome. Non-smokers. Free of major medical illness Exclusion Criteria: Women with myoma or adenomyosis Women with congenital uterine anomaly. Chronic use of any medications including non-steroidal anti-inflammatory drugs. Associated cases of infertility other than PCOs (male factor, tubal factor,….). Asherman syndrome. Cases with endometrial hyperplasia. Cases with endometrial polyp

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene

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