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Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness

Primary Purpose

Infertility, Female

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Sildenafil Citrate
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 Infertility, Female

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Beni-suef university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Sildenafil and clomiphene citrate

clomiphene citrate alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pregnancy rate
Serum pregnancy test (positive/negative)

Secondary Outcome Measures

endometrial thickness
measured by trans-vaginal ultrasound
ovulation rate
using trans-vaginal ultrasound

Full Information

First Posted
April 15, 2023
Last Updated
May 25, 2023
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05846906
Brief Title
Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness
Official Title
Oral Sildenafil Citrate: a Potential Approach for Improvement of Endometrial Thickness and Treatment of Unexplained Infertility in Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (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
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sildenafil and clomiphene citrate
Arm Type
Experimental
Arm Description
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.
Arm Title
clomiphene citrate alone
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sildenafil Citrate
Other Intervention Name(s)
respatio
Intervention Description
oral sildenafil (Respatio® 20mg )
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate 50mg
Other Intervention Name(s)
technovula
Intervention Description
used for ovionulation induct
Primary Outcome Measure Information:
Title
Pregnancy rate
Description
Serum pregnancy test (positive/negative)
Time Frame
at the end of the cycle (28 days)
Secondary Outcome Measure Information:
Title
endometrial thickness
Description
measured by trans-vaginal ultrasound
Time Frame
1 month
Title
ovulation rate
Description
using trans-vaginal ultrasound
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beni-Suef University
Organizational Affiliation
Faculty of Medicine 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 Oral Sildenafil Citrate on Improvement of Endometrial Thickness

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