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Sildenafil Effect After Ovulation Induction

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02890238
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
40
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

100 women with infertility classified into 2 groups.

Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.

Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.

Condition or Disease Intervention/Treatment Phase
  • Drug: Clomiphene citrate
  • Drug: sildenafil citrate
  • Drug: Placebo
 Phase 4

Detailed Description

100 women with infertility classified into 2 groups.

Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.

Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.

Folliculometry was assessed by:
  • Transvaginal ultrasound: It was done on day 11th of the cycle to detect number of follicles and endometrial thickness.

When the follicles reach ≥18 ml, injection of 5000 IU of HCG IM to trigger ovulation to both groups.

Pregnancy was assessed by:
  • Beta HCG test: (Radioimmunoassay)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Sildenafil Citrate on Pregnancy Rate in Women Undergoing Induction of Ovulation
Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Oct 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: sildenafil citrate

50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd - 7th day of the cycle and sildenafil citrate 20mg tab from 7th-11th day of the same cycle orally 3times/day

Drug: Clomiphene citrate
50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle
Other Names:
  • clomid

    • Drug: sildenafil citrate
    20mg tab from 7th-11th day of the same cycle orally 3times/day
    Other Names:
  • Viagra

    		•
    Placebo Comparator: placebo group

    50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd- 7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day

    Drug: Clomiphene citrate
    50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle
    Other Names:
  • clomid

    • Drug: Placebo
    tab from 7th-11th day of the same cycle orally 3times/day

    Outcome Measures

    Primary Outcome Measures

    1. Pregnancy rate per cycle [14 days after HCG triggering of ovulation]

      Serum pregnancy test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Infertile women whether it's primary or secondary infertility

    2. Woman's age: (18-35 years old)

    3. Menstrual cycle from (24-35 days)

    4. Normal semen analysis

    Exclusion Criteria:

    1. Age more than 35 years old

    2. Ovarian cysts

    3. Abnormal hormonal profile (e.g hyperprolactinaemia)

    4. Significant cardiovascular disease

    5. Serious liver disease or renal failure

    6. Poorly controlled diabetes mellitus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr Alainy medical school Cairo Egypt 12151

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Ahmed Maged, Kasr Alainy medical school

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed M Maged, MD, Assistant professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT02890238
    Other Study ID Numbers:
    • 156
    First Posted:
    Sep 7, 2016
    Last Update Posted:
    Sep 23, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Ahmed M Maged, MD, Assistant professor, Cairo University
    Sildenafil Citrate
    Induction of Ovulation
    Pregnancy Rate
    Additional relevant MeSH terms:
    Infertility
    Sildenafil Citrate
    Citric Acid
    Sodium Citrate
    Clomiphene
    Enclomiphene
    Zuclomiphene

    Study Results

    No Results Posted as of Sep 23, 2019