Recurrent Failures in assIsted Reproductive Techniques (The FIRST Registry)
A Registry on Outcomes in Women Undergoing Assisted Reproductive Techniques After Recurrent Failures
1 other identifier
observational
624
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 10, 2016
CompletedFirst Posted
Study publicly available on registry
February 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedJanuary 31, 2019
January 1, 2019
4.9 years
February 10, 2016
January 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of live births
10 months
Secondary Outcomes (1)
Number of clinical pregnancies after ART
10 months
Eligibility Criteria
Consecutive women undergoing ART after recurrent failures.
You may qualify if:
- or more implantation failures/losses of clinical pregnancies after ART
- ART cycle at enrolment
- Informed consent
You may not qualify if:
- Ovarian hypofunction
- Uterine pathology
- Hydrosalpinges
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013, Italy
Related Publications (1)
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.
PMID: 31409287DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elvira Grandone
IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo, Foggia, Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Unit
Study Record Dates
First Submitted
February 10, 2016
First Posted
February 19, 2016
Study Start
October 1, 2015
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
January 31, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will share