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

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Anovulatory

Treatments: Drug: Sildenafil & clomiphene citrate; Drug: clomiphene only

Study type: Interventional

Funder types: Other

Identifiers

NCT02663830

SIOO

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: Female

Ages: 21 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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210 participants in 2 patient groups

(Sildenafil & clomiphene citrate group)

Experimental group

Description:

105 Patients will receive 25 mg sildenafil citrate 6 hourly 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

Treatment:

Drug: Sildenafil & clomiphene citrate

clomiphene only

Active Comparator group

Description:

105 patients will receive only clomiphene citrate 100mg/day (day 2 to 6) orally (2 tablets at same time daily).

Treatment:

Drug: clomiphene only