The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene

The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene: A Randomized Controlled Trial.

The aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in women undergoing induction of ovulation using clomiphene citrate.

Study Overview

• Status: Completed
• Conditions: Anovulatory
• Intervention / Treatment: Drug: Sildenafil & clomiphene citrate; Drug: clomiphene only

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women age 21-35 years.
• Anovulatory cycles due to polycystic ovaries syndrome.
• Non-smokers.
• Free of major medical illness

Exclusion Criteria:

• Women with myoma or adenomyosis
• Women with congenital uterine anomaly.
• Chronic use of any medications including non-steroidal anti-inflammatory drugs.
• Associated cases of infertility other than PCOs (male factor, tubal factor,….).
• Asherman syndrome.
• Cases with endometrial hyperplasia.
• Cases with endometrial polyp

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: (Sildenafil & clomiphene citrate group); 105 Patients will receive 25 mg sildenafil citrate 6 hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation	Drug: Sildenafil & clomiphene citrate; 105 Patients will receive 25 mg sildenafil citrate 6hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation; Other Names: seldin and clomid
Active Comparator: clomiphene only; 105 patients will receive only clomiphene citrate 100mg/day (day 2 to 6) orally (2 tablets at same time daily).	Drug: clomiphene only; 105 Patients will receive clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation; Other Names: clomid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical pregnancy rate	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
endometrial thickness	2 weeks
miscarriage rate	13 weeks
ectopic pregnancy rate	8 weeks
Side Effects of Vasodilators	4 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2016
• Primary Completion (Actual): January 10, 2017
• Study Completion (Actual): March 12, 2017

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 13, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Anovulation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; 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; Clomiphene; Enclomiphene; Zuclomiphene
• Other Study ID Numbers: SIOO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided