Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness

Infertility, Female Clinical Trial

Official title:

Oral Sildenafil Citrate: a Potential Approach for Improvement of Endometrial Thickness and Treatment of Unexplained Infertility in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05846906
• Other study ID #: REC-H-PhBSU-21015
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2023
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Sildenafil Citrate
oral sildenafil (Respatio® 20mg )
• Clomiphene Citrate 50mg
used for ovionulation induct

Locations

Country	Name	City	State
Egypt	Beni-suef university	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	Serum pregnancy test (positive/negative)	at the end of the cycle (28 days)
Secondary	endometrial thickness	measured by trans-vaginal ultrasound	1 month
Secondary	ovulation rate	using trans-vaginal ultrasound	1 month