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

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ClinicalTrials.gov Identifier: NCT03044561
Recruitment Status : Unknown
Verified February 2017 by Amr El-Sayed, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Amr El-Sayed, Ain Shams University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
IVF Failure Drug: Sildenafil Citrate Drug: matching placebo Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Sildenafil Citrate on the Outcome of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : August 1, 2017
Estimated Study Completion Date : August 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sildenafil citrate Drug: Sildenafil Citrate
25 mg orally, 4 times per day for 21 days
Other Name: Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt

Placebo Comparator: placebo Drug: matching placebo
orally, 4 times per day for 21 days
Other Name: placebo




Primary Outcome Measures :
  1. endometrial thickness measures [ Time Frame: 21 days ]
    we will measure endometrial thickness by US in women with recurrent implantation failure



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044561


Contacts
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Contact: ahmed khairy, professor 01090808047

Locations
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Egypt
Ain shams university Recruiting
Cairo, Egypt
Contact: amr elsayed    01090808047      
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: ahmed khairy, professor Ain Shams University

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Responsible Party: Amr El-Sayed, principal investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03044561     History of Changes
Other Study ID Numbers: amr el-sayed 2017
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sildenafil Citrate
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents