Non-inferiority of cleavage-stage versus blastocyst-stage embryo transfer in poor prognosis IVF patients (PRECiSE trial): study protocol for a randomized controlled trial

Autor: Tom Toth, Alan S. Penzias, Werner M. Neuhausser, Denis A. Vaughan, Denny Sakkas, Michele R. Hacker
Rok vydání: 2019
Předmět:
Adult
Adolescent
Pregnancy Rate
medicine.medical_treatment
Fertilization in Vitro
lcsh:Gynecology and obstetrics
law.invention
Miscarriage
Andrology
03 medical and health sciences
Young Adult
Study Protocol
0302 clinical medicine
Randomized controlled trial
Cleavage-stage transfer
law
Pregnancy
In vitro fertilization
medicine
Humans
030212 general & internal medicine
Blastocyst
Prospective Studies
Birth Rate
lcsh:RG1-991
030219 obstetrics & reproductive medicine
In vitro fertilisation
business.industry
Blastocyst Transfer
Pregnancy Outcome
Obstetrics and Gynecology
Non-inferiority randomized controlled trial
Blastocyst transfer
medicine.disease
Embryo Transfer
Prognosis
Embryo transfer
3. Good health
Abortion
Spontaneous
Pregnancy rate
medicine.anatomical_structure
Reproductive Medicine
embryonic structures
Female
Live birth
business
Live Birth
Boston
Zdroj: Reproductive Health
Reproductive Health, Vol 17, Iss 1, Pp 1-10 (2020)
ISSN: 1742-4755
Popis: BackgroundWith improvements in in vitro culture techniques there has been a steady shift in practice to transfer embryos at the blastocyst stage (post fertilization day (p.f.d.) 5–7), when embryos reach the endometrial cavity during natural conception. For patients with > 5 zygotes on day 1 of embryo development, fresh blastocyst embryo transfer (ET) increases live birth rates when compared to cleavage stage (p.f.d. 3) transfer. In poorer prognosis patients (≤ 5 zygotes) cleavage stage ET is commonly performed to reduce the risk of cycle cancellation if no embryo survives to the blastocyst stage. However, there is a dearth of randomized controlled trial (RCT) data demonstrating improved live birth rates per cycle for cleavage vs blastocyst stage ET in this subgroup of patients. The hypothesis of the PRECiSE (PooR Embryo Yield Cleavage Stage Versus blaStocyst Embryo Transfer) trial is that blastocyst ET is not inferior to cleavage stage ET with regard to live birth rates per retrieval in poorer prognosis patients. The adoption of routine blastocyst culture for all patients would result in higher rates of single embryo transfers (SET), reduced incidence of multiple pregnancies and simplified laboratory protocols, thereby reducing costs.Methods/designMulticenter, non-inferiority randomized controlled trial (RCT) comparing blastocyst to cleavage stage embryo transfer in poorer prognosis patients with ≤5 zygotes on day 1 after fertilization. The primary outcome is live birth per retrieval. Secondary outcomes include: time to pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage and multiple pregnancy rate (per retrieval). This trial will enroll 658 women with ≤5 zygotes on day 1 at 6 IVF centers over the course of 22 months.DiscussionIf the hypothesis is proven true, the data from this trial may facilitate the adoption of uniform blastocyst culture in all IVF patients.Trial registrationClinicalTrials.gov Identifier:NCT03764865. Registered 5 December 2019, Protocol issue date: 4 December 2018, Original.
Databáze: OpenAIRE
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