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

Primary Purpose

Subfertility, Female

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
estrogen therapy
Sildenafil
Clomiphene Citrate 50mg
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subfertility, Female

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Beni-suef university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

estrogen therapy in addition to clomiphene citrate

sildenafil in addition to clomiphene citrate

clomiphene citrate alone

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 21, 2023
Last Updated
April 26, 2023
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05753098
Brief Title
Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy for Unexplained Infertility
Official Title
Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy on Improvement of Endometrial Thickness and Treatment of Unexplained Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
estrogen therapy in addition to clomiphene citrate
Arm Type
Experimental
Arm Description
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.
Arm Title
sildenafil in addition to clomiphene citrate
Arm Type
Experimental
Arm Description
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
Arm Title
clomiphene citrate alone
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
estrogen therapy
Other Intervention Name(s)
white tablet of cycloprogynova
Intervention Description
oral estradiol valerate
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Respatio
Intervention Description
PDE5 inhibitor
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate 50mg
Other Intervention Name(s)
Technovula
Intervention Description
used for ovulation induction
Primary Outcome Measure Information:
Title
pregnancy rates
Description
measure B HCG and detect number of cases get pregnant in each cycle 28 days
Time Frame
at the end of each of 3 cycles (28 days)
Secondary Outcome Measure Information:
Title
ovulation
Description
measuring dominant follicle starting from D9 of the cycle till reaching 18-20mm
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beni-Suef University
Organizational Affiliation
Clinical Pharmacy Faculty of Pharmacy Beni-Suef University
Official's Role
Study Director
Facility Information:
Facility Name
Beni-suef university
City
Banī Suwayf
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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