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

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

. 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.

Study Overview

• Status: Completed
• Conditions: Subfertility, Female
• Intervention / Treatment: Drug: estrogen therapy; Drug: Clomiphene Citrate 50mg; Drug: Sildenafil

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.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt
    • Beni-Suef University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: estrogen therapy in addition to clomiphene citrate; 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.	Drug: estrogen therapy; oral estradiol valerate; Other Names: white tablet of cycloprogynova; Drug: Clomiphene Citrate 50mg; used for ovulation induction; Other Names: Technovula
Experimental: sildenafil in addition to clomiphene citrate; 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	Drug: Clomiphene Citrate 50mg; used for ovulation induction; Other Names: Technovula; Drug: Sildenafil; PDE5 inhibitor; Other Names: Respatio
Other: clomiphene citrate alone; 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.	Drug: Clomiphene Citrate 50mg; used for ovulation induction; Other Names: Technovula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ovulation	measuring dominant follicle starting from D9 of the cycle till reaching 18-20mm	3 months

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Phosphodiesterase Inhibitors; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Estrogens; Clomiphene; Enclomiphene; Zuclomiphene
• Other Study ID Numbers: REC-H-PhBSU-22022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No