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Comparison of Clomiphene Alone Versus Clomiphene Plus Sildenafil for Ovulation in Women With Polycystic Ovary Syndrome

NCT07769476 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-08-18

No results posted yet for this study

Summary

The goal of this randomized clinical trial is to compare the effectiveness of clomiphene citrate alone with clomiphene citrate combined with sildenafil citrate for inducing ovulation and achieving pregnancy in women with polycystic ovary syndrome (PCOS) who have difficulty becoming pregnant.

The main question the study aims to answer is:

Does adding sildenafil citrate to clomiphene citrate increase the chance of ovulation and pregnancy compared with clomiphene citrate alone in women with PCOS?

The study will include 98 women aged 18-45 years with PCOS and a history of difficulty achieving pregnancy for more than 2 years. Participants will be randomly assigned to one of two groups.

* Participants in Group A will receive clomiphene citrate 100 mg once daily from days 3-7 of the menstrual cycle, plus sildenafil citrate 25 mg twice daily from days 8-12.
* Participants in Group B will receive clomiphene citrate 100 mg once daily from days 3-7, plus a placebo twice daily from days 8-12.

Treatment will be given for 12 weeks. Participants will be assessed for ovulation, pregnancy, and endometrial thickness. Ovulation will be assessed using transvaginal ultrasound and/or a blood progesterone test. Pregnancy will be assessed using a urine pregnancy test and/or ultrasound.

The primary hypothesis is that women receiving clomiphene citrate plus sildenafil citrate will have a higher rate of pregnancy than women receiving clomiphene citrate alone. The study will also determine whether adding sildenafil improves ovulation and endometrial thickness.

Conditions

  • Polycystic Ovarian Syndrome (PCOS)
  • Polyendocrine Metabolic Ovarian Syndrome (PMOS)

Interventions

DRUG

Clomiphene Citrate 100 mg

Clomiphene citrate 100 mg administered orally once daily from menstrual cycle days 3-7 for ovulation induction. Treatment will be repeated for 12 weeks.

DRUG

Sildenafil Citrate 25Mg Tab

Sildenafil citrate 25 mg administered orally twice daily from menstrual cycle days 8-12, in addition to clomiphene citrate, for ovulation induction. Treatment will be repeated for 12 weeks.

DRUG

Placebo

Matching placebo containing starch administered orally twice daily from menstrual cycle days 8-12, in addition to clomiphene citrate. Treatment will be repeated for 12 weeks.

Sponsors & Collaborators

  • Nishtar Medical University

    lead OTHER

Principal Investigators

  • Hajira M Associate Professor, FCPS · Nishtar Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • Pakistan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07769476 on ClinicalTrials.gov