Azathioprine in Recurrent Implantation Failure | NCT03498703

Studies
Azathioprine in Recurrent Implantation Failure

NCT03498703

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jul 24, 2019Actual

Enrollment

64Actual

Phase

Phase 2

Conditions

Recurrent Implantation Failure
In Vitro Fertilization
Intracytoplsmic Sperm Injection

Interventions

Azathioprine Pill
Placebo Oral Tablet

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2018Actual

Primary Completion Date

Jul 1, 2019Actual

Completion Date

Jul 1, 2019Actual

First Submitted Date

Apr 7, 2018

First Submission Date that Met QC Criteria

Apr 12, 2018

First Posted Date

Apr 17, 2018Actual

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

Jul 23, 2019

Last Update Posted Date

Jul 24, 2019Actual

Name	Class
Capital Birth Center	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Azathioprine	Experimental		Drug: Azathioprine Pill
Control	Placebo Comparator		Drug: Placebo Oral Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azathioprine Pill	Drug	Azathioprine increase pregnancy rate in cases with recurrent implantaion failure	Azathioprine

Measure	Description	Time Frame
Clinical pregnancy rate		2 weeks

Measure	Description	Time Frame
Side effects		2 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age: 20-39
previous 3 or more failed ivf

Exclusion Criteria:

intrauterine anomalies
chronic systemic illness
chronic pelvic conditions
sensitivety to azathioprine

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed H Salama	Capital Birth Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University, Maternity Hospital		Cairo			Egypt
Capital Birth Center

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001379	Azathioprine

Ancestor Terms

ID	Term
D013872	Thionucleosides
D013457	Sulfur Compounds
D009930	Organic Chemicals
D015122	Mercaptopurine

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Browse Branches

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