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

Effect of Sildenafil Citrate on the Outcome of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development

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

Study Overview

• Status: Unknown
• Conditions: IVF Failure
• Intervention / Treatment: Drug: Sildenafil Citrate; Drug: matching placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams University
    • Contact: amr elsayed; Phone Number: 01090808047

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: matching placebo; orally, 4 times per day for 21 days; Other Names: placebo
Experimental: Sildenafil citrate	Drug: Sildenafil Citrate; 25 mg orally, 4 times per day for 21 days; Other Names: Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endometrial thickness measures	we will measure endometrial thickness by US in women with recurrent implantation failure	21 days

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: ahmed khairy, professor, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2017
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 10, 2017

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: amr el-sayed 2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No