Sildenafil Citrate of in Vitro Fertilization After Multip... | NCT03044561

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

NCT03044561

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Feb 7, 2017Estimated

Enrollment

80Estimated

Phase

Phase 4

Conditions

IVF Failure

Interventions

Sildenafil Citrate
matching placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2017Actual

Primary Completion Date

Aug 1, 2017Estimated

Completion Date

Aug 10, 2017Estimated

First Submitted Date

Feb 2, 2017

First Submission Date that Met QC Criteria

Feb 3, 2017

First Posted Date

Feb 7, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2017

Last Update Posted Date

Feb 7, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sildenafil citrate	Experimental		Drug: Sildenafil Citrate
placebo	Placebo Comparator		Drug: matching placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sildenafil Citrate	Drug	25 mg orally, 4 times per day for 21 days	Sildenafil citrate

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ahmed khairy, professor	Contact	01090808047

Overall Officials

Name	Affiliation	Role
ahmed khairy, professor	Ain Shams University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain shams university	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Aug 9, 2017
Reset	Sep 6, 2017
Release	Feb 5, 2018
Reset	Oct 26, 2018

Submission Tracking

Estimated Results First Submitted Date

Aug 9, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 9, 2017			Sep 6, 2017
Feb 5, 2018

Intervention Browse Module

MeSH Terms

ID	Term
D000068677	Sildenafil Citrate
D013607	Tablets

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457

Browse Leaves

Not provided

Browse Branches

Not provided