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

Subfertility, Female Clinical Trial

Official title:

Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy on Improvement of Endometrial Thickness and Treatment of Unexplained Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05753098
• Other study ID #: REC-H-PhBSU-22022
• Status: Completed
• Phase: Phase 4
• Start date: January 15, 2021
• Est. completion date: January 31, 2023

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Subfertility, Female

Intervention

Drug:
• estrogen therapy
oral estradiol valerate
• Sildenafil
PDE5 inhibitor
• Clomiphene Citrate 50mg
used for ovulation induction

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 rates	measure B HCG and detect number of cases get pregnant in each cycle 28 days	at the end of each of 3 cycles (28 days)
Secondary	ovulation	measuring dominant follicle starting from D9 of the cycle till reaching 18-20mm	3 months