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

Anovulatory Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663830
• Other study ID #: SIOO
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2016
• Last updated: August 13, 2017
• Start date: January 10, 2016
• Est. completion date: March 12, 2017

Study information

• Verified date: August 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: March 12, 2017
• Est. primary completion date: January 10, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anovulatory

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate		6 weeks
Secondary	endometrial thickness		2 weeks
Secondary	miscarriage rate		13 weeks
Secondary	ectopic pregnancy rate		8 weeks
Secondary	Side Effects of Vasodilators		4 weeks