NCT03044561

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

February 2, 2017

Last Update Submit

February 3, 2017

Conditions

IVF Failure

Outcome Measures

Primary Outcomes (1)

  • endometrial thickness measures

    we will measure endometrial thickness by US in women with recurrent implantation failure

    21 days

Study Arms (2)

Sildenafil citrate

EXPERIMENTAL
Drug: Sildenafil Citrate

placebo

PLACEBO COMPARATOR
Drug: matching placebo

Interventions

Sildenafil CitrateDRUG

25 mg orally, 4 times per day for 21 days

Also known as: Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt
Sildenafil citrate
matching placeboDRUG

orally, 4 times per day for 21 days

Also known as: placebo
placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Sildenafil CitrateTablets

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDosage FormsPharmaceutical Preparations

Study Officials

  • ahmed khairy, professor

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

ahmed khairy, professor

CONTACT

01090808047

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 7, 2017

Study Start

January 31, 2017

Primary Completion

August 1, 2017

Study Completion

August 10, 2017

Last Updated

February 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Locations

EG(1)