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NCT Number: NCT02663830

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

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.

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Key information

Conditions

Anovulatory Adnexal Diseases Anovulation Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Urogenital Diseases

Age range

21 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Sildenafil & clomiphene citrate

Drug

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

clomiphene only

Drug

105 Patients will receive clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation

Other names: clomid

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 6 weeks

Secondary outcomes

  1. endometrial thickness

    Time frame: 2 weeks

  2. miscarriage rate

    Time frame: 13 weeks

  3. ectopic pregnancy rate

    Time frame: 8 weeks

  4. Side Effects of Vasodilators

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2016
Registry last updated
Aug 16, 2017

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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