Recurrent Failures in assIsted Reproductive Techniques (The FIRST Registry)

January 30, 2019 updated by: Elvira Grandone, MD, Head of Unit, Casa Sollievo della Sofferenza IRCCS

A Registry on Outcomes in Women Undergoing Assisted Reproductive Techniques After Recurrent Failures

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

624

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Recruiting
        • IRCCS Casa Sollievo della Sofferenza
        • Contact:
          • Elvira Grandone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Consecutive women undergoing ART after recurrent failures.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of live births
Time Frame: 10 months
10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of clinical pregnancies after ART
Time Frame: 10 months
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Casa Sollievo della Sofferenza IRCCS

Investigators

  • Principal Investigator: Elvira Grandone, IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo, Foggia, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 15, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIRST - V 1_28 Ago 15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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