Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness

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/PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-04-30

Brief Summary

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One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation.

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Detailed Description

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One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) orally twice daily from the second day of their cycle through the seventh day and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets from the end of menstruation through ovulation. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation, follicle count, and pregnancy. Consequences, including miscarriage, ectopic pregnancy, and multiple pregnancies, were monitored.

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Sildenafil and clomiphene citrate

Oral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the experimental group from day 2 through day 7 of the cycle, and oral sildenafil (Respatio® 20mg for 5 days) was taken from the last day of menstruation until reaching ovulation.

Group Type EXPERIMENTAL

Sildenafil Citrate

Intervention Type DRUG

oral sildenafil (Respatio® 20mg )

Clomiphene Citrate 50mg

Intervention Type DRUG

used for ovionulation induct

clomiphene citrate alone

Oral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the control group from day 2 through day 7 of the cycle in addition to a placebo tablet.

Group Type OTHER

Clomiphene Citrate 50mg

Intervention Type DRUG

used for ovionulation induct

Interventions

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Sildenafil Citrate

oral sildenafil (Respatio® 20mg )

Intervention Type DRUG

Clomiphene Citrate 50mg

used for ovionulation induct

Intervention Type DRUG

Other Intervention Names

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respatio technovula

Eligibility Criteria

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Inclusion Criteria

* ages of 18 to 40
* patent tubes
* unexplained infertility
* regular menstrual cycle
* husband with normal sperm parameters

Exclusion Criteria

* hypotension
* cardiovascular, renal and hepatic diseases
* uncontrolled diabetes mellitus
* anovulatory infertility
* abnormal thyroid functions
* ovarian cysts
* patients taking nitrates
* pelvic adhesions
* abnormal hormonal profile.
* hyperprolactinemia
* multiple uterine fibroids
* adenomyosis and endometriosis suspicion

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes