Recurrent Failures in assIsted Reproductive Techniques (T... | NCT02685800

Studies
Recurrent Failures in assIsted Reproductive Techniques (The FIRST Registry)

NCT02685800

Sponsor

Casa Sollievo della Sofferenza IRCCS

Status

Unknown status

Last Update Posted

Jan 31, 2019Actual

Enrollment

624Estimated

Phase

Not provided

Conditions

Infertility

Interventions

Not provided

Countries

Italy

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

Jan 2019

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

Oct 2015

Primary Completion Date

Sep 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Feb 10, 2016

First Submission Date that Met QC Criteria

Feb 15, 2016

First Posted Date

Feb 19, 2016Estimated

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

Jan 30, 2019

Last Update Posted Date

Jan 31, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elvira Grandone, MD, Head of Unit, Head of Unit, Casa Sollievo della Sofferenza IRCCSPrincipal Investigator

Lead Sponsor

Casa Sollievo della Sofferenza IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Assisted Reproductive Technologies (ARTs) are widely used in couples with fertility problems. However, despite ART treatment options have evolved over time, the implantation rate remains rather low.

A possible role for inherited and acquired thrombophilias has been invoked, especially in women with previous implantation failures. However, several factors could play a role in these conditions.

A potential benefit of low-molecular-weight heparin (LMWH) in improving ART outcomes, independently of the presence of thrombophilia, has been recently suggested.

This register is designed in order to better define all possible variables influencing ART outcome and improve clinical management of women with previous implantation failures. During this study the investigators will collect and evaluate clinical data regarding the first cycle in women with previous ART failures.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

624Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of live births		10 months

Secondary Outcomes

Measure	Description	Time Frame
Number of clinical pregnancies after ART		10 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

2 or more implantation failures/losses of clinical pregnancies after ART
ART cycle at enrolment
Informed consent

Exclusion Criteria:

Ovarian hypofunction
Uterine pathology
Hydrosalpinges
Previous inclusion in the study

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Consecutive women undergoing ART after recurrent failures.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elvira Grandone	Contact			e.grandone@operapadrepio.it
Michela Villani	Contact			mvillani27@libero.it

Overall Officials

Name	Affiliation	Role
Elvira Grandone	IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo, Foggia, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Casa Sollievo della Sofferenza	Recruiting	San Giovanni Rotondo	Foggia	71013	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31409287	Derived	Villani M, Baldini D, Totaro P, Larciprete G, Kovac M, Carone D, Passamonti SM, Permunian ET, Bartolotti T, Lojacono A, Cacciola R, Pinto GL, Bucherini E, De Stefano V, Lodigiani C, Lavopa C, Cho YS, Pizzicaroli C, Colaizzo D, Grandone E. Rationale and design of two prospective, multicenter, observational studies on reproductive outcome in women with recurrent failures after spontaneous or assisted conception: OTTILIA and FIRST registries. BMC Pregnancy Childbirth. 2019 Aug 13;19(1):292. doi: 10.1186/s12884-019-2444-y.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases