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

NCT07769476 | Completed Phase 4

• 1 other identifier: U1111-1345-1484
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Clomiphene Citrate; Sildenafil Citrate; Ovulation Induction; Pregnancy; Polycystic Ovarian Syndrome; Endometrial Thickness; Subfertility

Outcome Measures

Primary Outcomes (1)

• Pregnancy

  Pregnancy will be considered achieved when a urine human chorionic gonadotropin (hCG) test is positive after 7 days of a missed menstrual period and/or a gestational sac is detected by ultrasound.

  From initiation of treatment (1st cycle) through completion of third treatment cycle, up to 12 weeks

Other Outcomes (2)

• Ovulation

  From initiation of treatment (first cycle) through completion of the third cycle, up to 12 weeks

• Endometrial Thickness

  From initiation of treatment (first cycle) through completion of the third cycle, up to 12 weeks

Study Arms (2)

Clomiphene Citrate + Sildenafil Citrate

EXPERIMENTAL

Oral Clomiphene Citrate and Sildenafil Citrate will be given to participants in this Arm

Drug: Clomiphene Citrate 100 mg; Drug: Sildenafil Citrate 25Mg Tab

Clomiphene Citrate + Placebo

PLACEBO COMPARATOR

Participants in this arm will be given clomiphene citrate and placebo

Drug: Clomiphene Citrate 100 mg; Drug: Placebo

Interventions

Clomiphene Citrate 100 mg DRUG

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

Clomiphene Citrate + Placebo; Clomiphene Citrate + Sildenafil Citrate

Sildenafil Citrate 25Mg Tab DRUG

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.

Clomiphene Citrate + Sildenafil Citrate

Placebo DRUG

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.

Clomiphene Citrate + Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with PCOS,
• Sub-fertility attributed to PCOS, \> 2 years

You may not qualify if:

• Comorbidities; diabetes, hypertension
• Chronic medical illness (liver, heart, kidney disease)
• Undergone ovarian drilling
• Recent administration of hormonal therapy
• Abnormal prolactin levels (\>500 mIU/L), or thyroid function tests (TSH \>5.2 mIU/L, T3 \<70 ng/dl and T4 \<5.2 μg/dl)
• Obstructed fallopian tubes documented on hysterosalpingography and
• Abnormal semen analysis of their partners

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Medical University

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility

Interventions

Clomiphene; Sildenafil Citrate

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hajira M Associate Professor, FCPS

  Nishtar Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 18, 2026
• Study Start: July 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)