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

Michela Villani, Domenico Baldini, Pasquale Totaro, Giovanni Larciprete, Mirjana Kovac, Domenico Carone, Serena Maria Passamonti, Eleonora Tamborini Permunian, Tiziana Bartolotti, Andrea Lojacono, Rossella Cacciola, Giuliano Lo Pinto, Eugenio Bucherini, Valerio De Stefano, Corrado Lodigiani, Cristina Lavopa, Yoon Sung Cho, Caterina Pizzicaroli, Donatella Colaizzo, Elvira Grandone

Research output: Contribution to journalArticle

Abstract

Background: Spontaneous pregnancy loss and implantation failure after assisted reproductive technologies (ART) are very common occurrences. Although 50-60% of all cases remains unexplained, various predisposing factors, including thrombophilias, have been identified. Thus, the potential benefit of a prophylaxis with low-molecular-weight heparins in improving outcomes has been often investigated over the years. However, the majority of studies are observational and results from randomized clinical trials (RCTs) are inconclusive, probably due to heterogeneity and limited sample size. To cover these unmet needs and to have further data mainly based on the real-life clinical management, we designed these multicenter registries. Methods: OTTILIA (Observational sTudy on antiThrombotic prevention in thrombophILIA and pregnancy loss) and FIRST (recurrent Failures in assIsted Reproductive Techniques) registries are two prospective, multicenter, observational studies to evaluate pregnancy or ART outcomes in consecutive women with previous reproductive failures after spontaneous or assisted conception, respectively. All enrolled women are observed from their first visit after positive pregnancy test (OTTILIA) or before commencing a new ART cycle (FIRST) until the end of pregnancy or ART procedure (negative pregnancy test/end of pregnancy, if successful cycle), respectively. Data are collected by means of questionnaires and recorded in a central database. Follow-up investigations are performed during hospital stay, routine clinical follow-up visits or telephone interviews. Primary outcome is live birth rate in the OTTILIA register and clinical pregnancy rate in the FIRST. Discussion: Although RCTs are the 'gold standard' for evaluating treatment outcomes, we believe that our registries represent a valid alternative in improving knowledge on mechanisms involved in reproductive failures and supporting future clinical decisions. Trial registration: NCT 02385461, retrospectively registered 5 March 2015 (OTTILIA); NCT 02685800, registered 10 February 2016 (FIRST).

Original languageEnglish
Article number292
JournalBMC Pregnancy and Childbirth
Volume19
Issue number1
DOIs
Publication statusPublished - Aug 13 2019

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Assisted Reproductive Techniques
Multicenter Studies
Observational Studies
Registries
Pregnancy
Pregnancy Tests
Randomized Controlled Trials
Thrombophilia
Birth Rate
Low Molecular Weight Heparin
Live Birth
Pregnancy Rate
Causality
Sample Size
Length of Stay
Databases
Interviews

Keywords

  • Assisted reproductive technologies
  • Heparins
  • Implantation failure
  • Observational study
  • Pregnancy loss
  • Risk factors
  • Thrombophilia

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

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. / Villani, Michela; Baldini, Domenico; Totaro, Pasquale; Larciprete, Giovanni; Kovac, Mirjana; Carone, Domenico; Passamonti, Serena Maria; Permunian, Eleonora Tamborini; Bartolotti, Tiziana; Lojacono, Andrea; Cacciola, Rossella; Pinto, Giuliano Lo; Bucherini, Eugenio; De Stefano, Valerio; Lodigiani, Corrado; Lavopa, Cristina; Cho, Yoon Sung; Pizzicaroli, Caterina; Colaizzo, Donatella; Grandone, Elvira.

In: BMC Pregnancy and Childbirth, Vol. 19, No. 1, 292, 13.08.2019.

Research output: Contribution to journalArticle

Villani, Michela ; Baldini, Domenico ; Totaro, Pasquale ; Larciprete, Giovanni ; Kovac, Mirjana ; Carone, Domenico ; Passamonti, Serena Maria ; Permunian, Eleonora Tamborini ; Bartolotti, Tiziana ; Lojacono, Andrea ; Cacciola, Rossella ; Pinto, Giuliano Lo ; Bucherini, Eugenio ; De Stefano, Valerio ; Lodigiani, Corrado ; Lavopa, Cristina ; Cho, Yoon Sung ; Pizzicaroli, Caterina ; Colaizzo, Donatella ; Grandone, Elvira. / 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. In: BMC Pregnancy and Childbirth. 2019 ; Vol. 19, No. 1.
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T2 - OTTILIA and FIRST registries

AU - Villani, Michela

AU - Baldini, Domenico

AU - Totaro, Pasquale

AU - Larciprete, Giovanni

AU - Kovac, Mirjana

AU - Carone, Domenico

AU - Passamonti, Serena Maria

AU - Permunian, Eleonora Tamborini

AU - Bartolotti, Tiziana

AU - Lojacono, Andrea

AU - Cacciola, Rossella

AU - Pinto, Giuliano Lo

AU - Bucherini, Eugenio

AU - De Stefano, Valerio

AU - Lodigiani, Corrado

AU - Lavopa, Cristina

AU - Cho, Yoon Sung

AU - Pizzicaroli, Caterina

AU - Colaizzo, Donatella

AU - Grandone, Elvira

PY - 2019/8/13

Y1 - 2019/8/13

N2 - Background: Spontaneous pregnancy loss and implantation failure after assisted reproductive technologies (ART) are very common occurrences. Although 50-60% of all cases remains unexplained, various predisposing factors, including thrombophilias, have been identified. Thus, the potential benefit of a prophylaxis with low-molecular-weight heparins in improving outcomes has been often investigated over the years. However, the majority of studies are observational and results from randomized clinical trials (RCTs) are inconclusive, probably due to heterogeneity and limited sample size. To cover these unmet needs and to have further data mainly based on the real-life clinical management, we designed these multicenter registries. Methods: OTTILIA (Observational sTudy on antiThrombotic prevention in thrombophILIA and pregnancy loss) and FIRST (recurrent Failures in assIsted Reproductive Techniques) registries are two prospective, multicenter, observational studies to evaluate pregnancy or ART outcomes in consecutive women with previous reproductive failures after spontaneous or assisted conception, respectively. All enrolled women are observed from their first visit after positive pregnancy test (OTTILIA) or before commencing a new ART cycle (FIRST) until the end of pregnancy or ART procedure (negative pregnancy test/end of pregnancy, if successful cycle), respectively. Data are collected by means of questionnaires and recorded in a central database. Follow-up investigations are performed during hospital stay, routine clinical follow-up visits or telephone interviews. Primary outcome is live birth rate in the OTTILIA register and clinical pregnancy rate in the FIRST. Discussion: Although RCTs are the 'gold standard' for evaluating treatment outcomes, we believe that our registries represent a valid alternative in improving knowledge on mechanisms involved in reproductive failures and supporting future clinical decisions. Trial registration: NCT 02385461, retrospectively registered 5 March 2015 (OTTILIA); NCT 02685800, registered 10 February 2016 (FIRST).

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KW - Observational study

KW - Pregnancy loss

KW - Risk factors

KW - Thrombophilia

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