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Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness

Sponsor
Beni-Suef University (Other)
Overall Status
Completed
CT.gov ID
NCT05846906
Collaborator
(none)
130
Enrollment
1
Location
2
Arms
6.9
Actual Duration (Months)
18.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sildenafil Citrate
  • Drug: Clomiphene Citrate 50mg
 Phase 2/Phase 3

Detailed Description

One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) orally twice daily from the second day of their cycle through the seventh day and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets from the end of menstruation through ovulation. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation, follicle count, and pregnancy. Consequences, including miscarriage, ectopic pregnancy, and multiple pregnancies, were monitored.

Study Design

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Oral Sildenafil Citrate: a Potential Approach for Improvement of Endometrial Thickness and Treatment of Unexplained Infertility in Women
Actual Study Start Date :
Oct 1, 2021
Actual Primary Completion Date :
Apr 30, 2022
Actual Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sildenafil and clomiphene citrate

Oral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the experimental group from day 2 through day 7 of the cycle, and oral sildenafil (Respatio® 20mg for 5 days) was taken from the last day of menstruation until reaching ovulation.

Drug: Sildenafil Citrate
oral sildenafil (Respatio® 20mg )
Other Names:
  • respatio

    • Drug: Clomiphene Citrate 50mg
    used for ovionulation induct
    Other Names:
  • technovula

    		•
    Other: clomiphene citrate alone

    Oral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the control group from day 2 through day 7 of the cycle in addition to a placebo tablet.

    Drug: Clomiphene Citrate 50mg
    used for ovionulation induct
    Other Names:
  • technovula

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pregnancy rate [at the end of the cycle (28 days)]

      Serum pregnancy test (positive/negative)

    Secondary Outcome Measures

    1. endometrial thickness [1 month]

      measured by trans-vaginal ultrasound

    2. ovulation [1 month]

      using trans-vaginal ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • ages of 18 to 40

    • patent tubes

    • unexplained infertility

    • regular menstrual cycle

    • husband with normal sperm parameters

    Exclusion Criteria:

    • hypotension

    • cardiovascular, renal and hepatic diseases

    • uncontrolled diabetes mellitus

    • anovulatory infertility

    • abnormal thyroid functions

    • ovarian cysts

    • patients taking nitrates

    • pelvic adhesions

    • abnormal hormonal profile.

    • hyperprolactinemia

    • multiple uterine fibroids

    • adenomyosis and endometriosis suspicion

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beni-suef university Banī Suwayf Egypt

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

    • Study Director: Beni-Suef University, Faculty of Medicine Beni-Suef University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Abdallah Mohamed Salem, Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT05846906
    Other Study ID Numbers:
    • REC-H-PhBSU-21015
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female
    Sildenafil Citrate
    Citric Acid
    Sodium Citrate
    Clomiphene
    Enclomiphene
    Zuclomiphene

    Study Results

    No Results Posted as of May 6, 2023