Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness
Oral Sildenafil Citrate: a Potential Approach for Improvement of Endometrial Thickness and Treatment of Unexplained Infertility in Women
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2021
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedFirst Submitted
Initial submission to the registry
April 15, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedMay 30, 2023
May 1, 2023
7 months
April 15, 2023
May 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Pregnancy rate
Serum pregnancy test (positive/negative)
at the end of the cycle (28 days)
Secondary Outcomes (2)
endometrial thickness
1 month
ovulation rate
1 month
Study Arms (2)
Sildenafil and clomiphene citrate
EXPERIMENTALOral 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.
clomiphene citrate alone
OTHEROral 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.
Interventions
oral sildenafil (Respatio® 20mg )
used for ovionulation induct
Eligibility Criteria
You may qualify if:
- ages of 18 to 40
- patent tubes
- unexplained infertility
- regular menstrual cycle
- husband with normal sperm parameters
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beni-suef university
Banī Suwayf, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Beni-Suef University
Faculty of Medicine Beni-Suef University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Study Record Dates
First Submitted
April 15, 2023
First Posted
May 6, 2023
Study Start
October 1, 2021
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
May 30, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share