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Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy for Unexplained Infertility

Sponsor
Beni-Suef University (Other)
Overall Status
Completed
CT.gov ID
NCT05753098
Collaborator
(none)
148
Enrollment
1
Location
3
Arms
24.5
Actual Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

. This study aimed to determine and compare the effect of vaginal sildenafil citrate and estradiol valerate on endometrial thickness, blood flow and pregnancy rates in infertile women.

Condition or Disease Intervention/Treatment Phase
  • Drug: estrogen therapy
 Phase 4

Detailed Description

The study is a randomized controlled trial that was carried on 148 infertile women with unexplained infertility. Patients were divided into 3 groups. Group 1 included 48 patients who received oral estradiol valerate (Cyclo-Progynova 2mg, from day 8th till triggering of ovulation), another 50 patients in group 2 received oral Sildenafil (Respatio 20mg/12hr film coated tablets for 5 days starting from last day of menstruation till ovulation), while group 3 was the control one who included 50 patients were given ovulation induction with CC 50mg/12hr from 2nd to 7th day of cycle. Every patient underwent a transvaginal ultrasound to determine ovulation, number of follicles, and pregnancy rates. Miscarriage, ectopic pregnancy, and multiple pregnancies were tracked for 3 months, as were any adverse consequences.

Study Design

Study Type:
Interventional
Actual Enrollment :
148 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy on Improvement of Endometrial Thickness and Treatment of Unexplained Infertility
Actual Study Start Date :
Jan 15, 2021
Actual Primary Completion Date :
Jan 31, 2023
Actual Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: estrogen therapy in addition to clomiphene citrate

received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle and estrogen (Cyclopregnova® 2mg, white tablets, BAYER Schering pharma), one tablet every 12 hour from day 8th till triggering of ovulation.

Drug: estrogen therapy
oral estradiol valerate
Other Names:
  • white tablet of cycloprogynova

    		•
    Experimental: sildenafil in addition to clomiphene citrate

    received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as and Sildenafil (Respatio® 20mg film coated tablets for 5 days) from last day of menstruation till reaching optimal size of follicle and endometrial thickness

    Drug: estrogen therapy
    oral estradiol valerate
    Other Names:
  • white tablet of cycloprogynova

    		•
    No Intervention: clomiphene citrate alone

    received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as in the first and second groups in addition to placebo tablet.

    Outcome Measures

    Primary Outcome Measures

    1. pregnancy rates [at the end of each of 3 cycles (28 days)]

      measure B HCG and detect number of cases get pregnant in each cycle 28 days

    Secondary Outcome Measures

    1. ovulation [3 months]

      measuring dominant follicle starting from D9 of the cycle till reaching 18-20mm

    Eligibility Criteria

    Criteria

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

    • aged between 18 to 40 years

    • unexplained infertility (primary or secondary)

    • had a regular menstrual cycle;

    • patent tubes;

    • husbands with normal semen parameters.

    Exclusion Criteria:

    • hypotension;

    • cardiovascular, hepatic, and renal diseases;

    • uncontrolled diabetes mellitus;

    • anovulatory infertility;

    • ovarian cysts;

    • pelvic adhesions;

    • hyperprolactinemia;

    • abnormal thyroid functions;

    • multiple uterine fibroids;

    • patients on nitrates;

    • suspicion of endometriosis and adenomyosis,

    • subjects have known to receive any treatment for fertility in the last six months

    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, Clinical Pharmacy Faculty of Pharmacy 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:
    NCT05753098
    Other Study ID Numbers:
    • REC-H-PhBSU-22022
    First Posted:
    Mar 3, 2023
    Last Update Posted:
    Mar 3, 2023
    Last Verified:
    Mar 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
    Estrogens

    Study Results

    No Results Posted as of Mar 3, 2023