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

NCT ID: NCT02663830

Last Updated: 2017-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-10

Study Completion Date

2017-03-12

Brief Summary

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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.

Detailed Description

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Conditions

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Anovulatory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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(Sildenafil & clomiphene citrate group)

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

Group Type EXPERIMENTAL

Sildenafil & clomiphene citrate

Intervention Type 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

clomiphene only

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

Group Type ACTIVE_COMPARATOR

clomiphene only

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

clomiphene only

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

Intervention Type DRUG

Other Intervention Names

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seldin and clomid clomid

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdel Shafy El Shahawy

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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SIOO

Identifier Type: -

Identifier Source: org_study_id

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