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NCT Number: NCT07769476

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

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.

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Key information

Conditions

Polycystic Ovarian Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Polyendocrine Metabolic Ovarian Syndrome (PMOS) Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nishtar Medical University

Multan, Punjab Province, 60000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Pregnancy

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

    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.

Other outcomes

  1. Ovulation

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

    Ovulation will be considered present when a collapsed follicle and free fluid in the pouch of Douglas are observed on transvaginal ultrasound and/or serum progesterone is ≥3 ng/mL. Transvaginal ultrasound will be start around cycle day 10-12, then repeat every 1-2 days until evidence of ovulation. Serum progesterone will be measured approximately 7 days after the expected ovulation (often around cycle day 21 in a 28-day cycle).

  2. Endometrial Thickness

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

    Endometrial thickness will be measured by transvaginal ultrasonography once during each treatment cycle, at the peri-ovulatory assessment when the dominant follicle reaches approximately 18-22 mm in diameter, before evidence of follicular rupture. Measurements will therefore be obtained during each of the three treatment cycles.

Sponsors and collaborators

Lead sponsor

Nishtar Medical University

Other

Registry information

Official study title

Comparison of Clomiphene Citrate Alone Versus Clomiphene Citrate Plus Sildenafil Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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