Recurrent Failures in assIsted Reproductive Techniques (The FIRST Registry)

NCT ID: NCT02685800

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

624 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2020-09-30

Brief Summary

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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

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Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Casa Sollievo della Sofferenza IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Elvira Grandone, MD, Head of Unit

Head of Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elvira Grandone

Role: PRINCIPAL_INVESTIGATOR

IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo, Foggia, Italy

Locations

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IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elvira Grandone

Role: CONTACT

Michela Villani

Role: CONTACT

Facility Contacts

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Elvira Grandone

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31409287 (View on PubMed)

Other Identifiers

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FIRST - V 1_28 Ago 15

Identifier Type: -

Identifier Source: org_study_id

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