Sildenafil Citrate of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development

NCT ID: NCT03044561

Last Updated: 2017-02-07

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-08-10

Brief Summary

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The aim of this study is to evaluate the effect of sildenafil citrate on endometrial development in women with history of recurrent implantation failure after IVF

Detailed Description

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sildenafil citrate may increase endometrial thickness in women with recurrent IVF failure attributed to poor endometrial development

Conditions

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IVF Failure

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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Sildenafil citrate

Group Type EXPERIMENTAL

Sildenafil Citrate

Intervention Type DRUG

25 mg orally, 4 times per day for 21 days

placebo

Group Type PLACEBO_COMPARATOR

matching placebo

Intervention Type DRUG

orally, 4 times per day for 21 days

Interventions

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Sildenafil Citrate

25 mg orally, 4 times per day for 21 days

Intervention Type DRUG

matching placebo

orally, 4 times per day for 21 days

Intervention Type DRUG

Other Intervention Names

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Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt placebo

Eligibility Criteria

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Inclusion Criteria

* (1) cases of infertility, older than 20 years of age and not older than 40 years.
* (2) Body mass index (BMI):20-29.
* (3) women have experienced two or more implantation failure attributed to inadequate endometrial development.

Exclusion Criteria

* (1) Uterine abnormalities (e.g. septate, bicornuate and fibroid uterus, Asherman Syndrome).
* (2) Any contraindication to sildenafil citrate or any of the components of its formulation including:

* Concurrent use of organic nitrites and nitrates.
* Severe hepatic impairment.
* Severe renal impairment.
* Hypotension.
* Recent stroke or heart attack.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Amr El-Sayed

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed khairy, professor

Role: STUDY_DIRECTOR

Ain Shams University

Locations

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Ain shams university

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ahmed khairy, professor

Role: CONTACT

01090808047

Facility Contacts

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amr elsayed

Role: primary

01090808047

Other Identifiers

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amr el-sayed 2017

Identifier Type: -

Identifier Source: org_study_id

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