Natural vs. programmed cycles for frozen embryo transfer: study protocol for an investigator-initiated, randomized, controlled, multicenter clinical trial.

Cryopreservation Embryo Transfer Female Humans Live Birth Multicenter Studies as Topic Pregnancy Pregnancy Rate Randomized Controlled Trials as Topic Reproductive Techniques, Assisted Retrospective Studies
Frozen-thawed embryo transfer Modified natural cycle Preeclampsia Programmed cycle

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
27 Sep 2021
Historique:
received: 06 04 2021
accepted: 15 09 2021
entrez: 28 9 2021
pubmed: 29 9 2021
medline: 30 9 2021
Statut: epublish

Résumé

Randomized trials of assisted reproductive technology (ART) have been designed for outcomes of clinical pregnancy or live birth and have not been powered for obstetric outcomes such as preeclampsia, critical for maternal and fetal health. ART increasingly involves frozen embryo transfer (FET). Although there are advantages of FET, multiple studies have shown that risk of preeclampsia is increased with FET compared with fresh embryo transfer, and the reason for this difference is not clear. NatPro will compare the proportion of preeclampsia between two commonly used protocols for FET,modified natural and programmed cycle. In this two-arm, parallel-group, multi-center randomized trial, NatPro will randomize 788 women to either modified natural or programmed FET and follow them for up to three FET cycles. Primary outcome will be the proportion of preeclampsia in women with a viable pregnancy assigned to a modified natural cycle FET (corpus luteum present) protocol compared to the proportion of preeclampsia in pregnant women assigned to a programmed FET (corpus luteum absent) protocol. Secondary outcomes will compare the proportion of live births and the proportion of preeclampsia with severe features between the protocols. This study has a potential significant impact on millions of women who pursue ART to build their families. NatPro is designed to provide clinically relevant guidance to inform patients and clinicians regarding maternal risk with programmed and modified natural cycle FET protocols. This study will also provide accurate point estimates regarding the likelihood of live birth with programmed and modified natural cycle FET. ClinicalTrials.gov NCT04551807 . Registered on September 16, 2020.

Sections du résumé

BACKGROUND BACKGROUND
Randomized trials of assisted reproductive technology (ART) have been designed for outcomes of clinical pregnancy or live birth and have not been powered for obstetric outcomes such as preeclampsia, critical for maternal and fetal health. ART increasingly involves frozen embryo transfer (FET). Although there are advantages of FET, multiple studies have shown that risk of preeclampsia is increased with FET compared with fresh embryo transfer, and the reason for this difference is not clear. NatPro will compare the proportion of preeclampsia between two commonly used protocols for FET,modified natural and programmed cycle.
METHODS METHODS
In this two-arm, parallel-group, multi-center randomized trial, NatPro will randomize 788 women to either modified natural or programmed FET and follow them for up to three FET cycles. Primary outcome will be the proportion of preeclampsia in women with a viable pregnancy assigned to a modified natural cycle FET (corpus luteum present) protocol compared to the proportion of preeclampsia in pregnant women assigned to a programmed FET (corpus luteum absent) protocol. Secondary outcomes will compare the proportion of live births and the proportion of preeclampsia with severe features between the protocols.
CONCLUSION CONCLUSIONS
This study has a potential significant impact on millions of women who pursue ART to build their families. NatPro is designed to provide clinically relevant guidance to inform patients and clinicians regarding maternal risk with programmed and modified natural cycle FET protocols. This study will also provide accurate point estimates regarding the likelihood of live birth with programmed and modified natural cycle FET.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov NCT04551807 . Registered on September 16, 2020.

Identifiants

DOI: 10.1186/s13063-021-05637-3 PMID: 34579768 PMC: PMC8477459
pubmed: 34579768
doi: 10.1186/s13063-021-05637-3
pii: 10.1186/s13063-021-05637-3
pmc: PMC8477459
doi:

Banques de données

ClinicalTrials.gov
['NCT04551807']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

660

Subventions

Organisme : National Institute of Child Health and Human Development
ID : R01HD100305
Organisme : NICHD NIH HHS
ID : R01 HD100341
Pays : United States
Organisme : NICHD NIH HHS
ID : R01 HD100305
Pays : United States
Organisme : National Institute of Child Health and Human Development
ID : R01HD100341
Organisme : National Institute of Child Health and Human Development
ID : R01HD100334

Investigateurs

Lusine Aghajanova (L)
Ruben Alvero (R)
Mary Andrews (M)
Diego Arevalo (D)
Emily Barnard (E)
Aracely Casillas (A)
Morgan Copeland (M)
La Tasha B Craig (TB)
Kathleen M Doody (KM)
Ashley Eskew (A)
Alma Gonzalez (A)
Gretchen Hoelscher (G)
Arthur Jason Vaught (AJ)
Lynda Kochman (L)
Andie Lears (A)
Gaya Murugappan (G)
Anna C Nackley (AC)
Tasha Newsome (T)
Natalie Quintana (N)
Bhuchitra Singh (B)
Anna Sokalska (A)
Michelle Starkey-Scruggs (M)
Robin L Thomas (RL)
Deveine Toney (D)
Irene Trueheart (I)
Kisha Turner (K)
Rebecca Usadi (R)
Sally Villalobos (S)
Anjali Wignarajah (A)
Virginia Winn (V)
Christy Zones (C)

Informations de copyright

© 2021. The Author(s).

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Auteurs

Sheriza Baksh (S)

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 415 N. Washington Street, 2nd Floor, Baltimore, MD, 21231, USA. sbaksh4@jhu.edu.
Center for Clinical Trials and Evidence Synthesis, Johns Hopkins University, Baltimore, MD, 21205, USA. sbaksh4@jhu.edu.
ORCID: 0000-0002-8341-860X

Anne Casper (A)

Center for Clinical Trials and Evidence Synthesis, Johns Hopkins University, Baltimore, MD, 21205, USA.

Mindy S Christianson (MS)

Division of Reproductive Endocrinology and Infertility, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD, 21205, USA.

Kate Devine (K)

Shady Grove Fertility, Washington, DC, 20006, USA.

Kevin J Doody (KJ)

CARE Fertility, Bedford, TX, 76022, USA.

Stephan Ehrhardt (S)

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 415 N. Washington Street, 2nd Floor, Baltimore, MD, 21231, USA.
Center for Clinical Trials and Evidence Synthesis, Johns Hopkins University, Baltimore, MD, 21205, USA.

Karl R Hansen (KR)

Section of Reproductive Endocrinoloogy and Infertility, Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK, 73104, USA.

Ruth B Lathi (RB)

Department of Obstetrics and Gynecology, Stanford University Medical Center, Sunnyvale, CA, 94087, USA.

Fatmata Timbo (F)

Center for Clinical Trials and Evidence Synthesis, Johns Hopkins University, Baltimore, MD, 21205, USA.

Rebecca Usadi (R)

Atrium Health, Charlotte, NC, 28203, USA.

Wendy Vitek (W)

University of Rochester Medical Center, Rochester, NY, 14642, USA.

David M Shade (DM)

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 415 N. Washington Street, 2nd Floor, Baltimore, MD, 21231, USA.
Center for Clinical Trials and Evidence Synthesis, Johns Hopkins University, Baltimore, MD, 21205, USA.

James Segars (J)

Division of Reproductive Endocrinology and Infertility, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD, 21205, USA.

Valerie L Baker (VL)

Division of Reproductive Endocrinology and Infertility, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD, 21205, USA.

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Classifications MeSH

questionsmedicales.fr › Techniques d'investigation › Conservation biologique › Cryoconservation › Natural vs. programmed cycles for frozen...
questionsmedicales.fr › Techniques d'investigation › Techniques de reproduction › Techniques de reproduction assistée › Transfert d'embryon › Natural vs. programmed cycles for frozen...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Natural vs. programmed cycles for frozen...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Reproduction › Grossesse › Issue de la grossesse › Naissance vivante › Natural vs. programmed cycles for frozen...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études multicentriques comme sujet › Natural vs. programmed cycles for frozen...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Reproduction › Grossesse › Natural vs. programmed cycles for frozen...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Registre civil › Taux de grossesse › Natural vs. programmed cycles for frozen...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Natural vs. programmed cycles for frozen...
questionsmedicales.fr › Techniques d'investigation › Techniques de reproduction › Techniques de reproduction assistée › Natural vs. programmed cycles for frozen...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études rétrospectives › Natural vs. programmed cycles for frozen...