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Status unknownNCT02685800Updated Jan 31, 2019

Recurrent Failures in assIsted Reproductive Techniques (The FIRST Registry)

An observational study in Infertility, sponsored by Casa Sollievo della Sofferenza IRCCS. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-01-31.

Sponsored by Casa Sollievo della Sofferenza IRCCS · Observational

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
624
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility

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03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 624 is above the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Casa Sollievo della Sofferenza IRCCS is the lead sponsor of 18 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Consecutive women undergoing ART after recurrent failures.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Ovarian hypofunction
  • Uterine pathology
  • Hydrosalpinges
  • Previous inclusion in the study
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
624 participants (estimated)
Target follow-up
10 Months
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. Number of live births

    Time frame: 10 months

Secondary outcomes

  1. Number of clinical pregnancies after ART

    Time frame: 10 months

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Study locations

1 of 1 sites recruiting
  • IRCCS Casa Sollievo della Sofferenza
    San Giovanni Rotondo, Foggia 71013, Italy
    • Elvira Grandone · Contact
    Recruiting
08

References and documents

Publications

  • 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. PubMed 31409287 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02685800
Lead sponsor
Casa Sollievo della Sofferenza IRCCS
Responsible party
Elvira Grandone, MD, Head of Unit (Head of Unit, Casa Sollievo della Sofferenza IRCCS) — Principal investigator
First posted
Feb 19, 2016
Start date
Oct 2015
Primary completion
Sep 2020 (estimated)
Completion
Sep 2020 (estimated)
Last update
Jan 31, 2019

Study contacts

Elvira Grandone
Contact
e.grandone@operapadrepio.it
Michela Villani
Contact
mvillani27@libero.it
Elvira Grandone
principal investigator · IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo, Foggia, Italy

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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