Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy for Unexplained Infertility

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

PHASE4

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2023-01-31

Brief Summary

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. This study aimed to determine and compare the effect of vaginal sildenafil citrate and estradiol valerate on endometrial thickness, blood flow and pregnancy rates in infertile women.

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Detailed Description

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The study is a randomized controlled trial that was carried on 148 infertile women with unexplained infertility. Patients were divided into 3 groups. Group 1 included 48 patients who received oral estradiol valerate (Cyclo-Progynova 2mg, from day 8th till triggering of ovulation), another 50 patients in group 2 received oral Sildenafil (Respatio 20mg/12hr film coated tablets for 5 days starting from last day of menstruation till ovulation), while group 3 was the control one who included 50 patients were given ovulation induction with CC 50mg/12hr from 2nd to 7th day of cycle. Every patient underwent a transvaginal ultrasound to determine ovulation, number of follicles, and pregnancy rates. Miscarriage, ectopic pregnancy, and multiple pregnancies were tracked for 3 months, as were any adverse consequences.

Conditions

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Subfertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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estrogen therapy in addition to clomiphene citrate

received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle and estrogen (Cyclopregnova® 2mg, white tablets, BAYER Schering pharma), one tablet every 12 hour from day 8th till triggering of ovulation.

Group Type EXPERIMENTAL

estrogen therapy

Intervention Type DRUG

oral estradiol valerate

Clomiphene Citrate 50mg

Intervention Type DRUG

used for ovulation induction

sildenafil in addition to clomiphene citrate

received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as and Sildenafil (Respatio® 20mg film coated tablets for 5 days) from last day of menstruation till reaching optimal size of follicle and endometrial thickness

Group Type EXPERIMENTAL

Sildenafil

Intervention Type DRUG

PDE5 inhibitor

Clomiphene Citrate 50mg

Intervention Type DRUG

used for ovulation induction

clomiphene citrate alone

received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as in the first and second groups in addition to placebo tablet.

Group Type OTHER

Clomiphene Citrate 50mg

Intervention Type DRUG

used for ovulation induction

Interventions

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estrogen therapy

oral estradiol valerate

Intervention Type DRUG

Sildenafil

PDE5 inhibitor

Intervention Type DRUG

Clomiphene Citrate 50mg

used for ovulation induction

Intervention Type DRUG

Other Intervention Names

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white tablet of cycloprogynova Respatio Technovula

Eligibility Criteria

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Inclusion Criteria

* aged between 18 to 40 years
* unexplained infertility (primary or secondary)
* had a regular menstrual cycle;
* patent tubes;
* husbands with normal semen parameters.

Exclusion Criteria

* hypotension;
* cardiovascular, hepatic, and renal diseases;
* uncontrolled diabetes mellitus;
* anovulatory infertility;
* ovarian cysts;
* pelvic adhesions;
* hyperprolactinemia;
* abnormal thyroid functions;
* multiple uterine fibroids;
* patients on nitrates;
* suspicion of endometriosis and adenomyosis,
* subjects have known to receive any treatment for fertility in the last six months

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes