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Sildenafil Effect After Ovulation Induction

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ClinicalTrials.gov Identifier: NCT02890238
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed M Maged, MD, Cairo University

Tracking Information
First Submitted Date  ICMJE August 29, 2016
First Posted Date  ICMJE September 7, 2016
Last Update Posted Date September 23, 2019
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
Pregnancy rate per cycle [ Time Frame: 14 days after HCG triggering of ovulation ]
Serum pregnancy test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sildenafil Effect After Ovulation Induction
Official Title  ICMJE Effect of Sildenafil Citrate on Pregnancy Rate in Women Undergoing Induction of Ovulation
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: Clomiphene citrate
    50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle
    Other Name: clomid
  • Drug: sildenafil citrate
    20mg tab from 7th-11th day of the same cycle orally 3times/day
    Other Name: Viagra
  • Drug: Placebo
    tab from 7th-11th day of the same cycle orally 3times/day
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Clomiphene citrate
    • Drug: sildenafil citrate
  • 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
    Interventions:
    • Drug: Clomiphene citrate
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ahmed Maged 01005227404 prof.ahmedmaged@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02890238
Other Study ID Numbers  ICMJE 156
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Ahmed M Maged, MD, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmed Maged Kasr Alainy medical school
PRS Account Cairo University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP