Back to Search
Start Over
The effect of laser-assisted hatching on vitrified/warmed blastocysts: the ALADDIN randomized controlled trial.
- Source :
-
Fertility and sterility [Fertil Steril] 2024 Jul; Vol. 122 (1), pp. 106-113. Date of Electronic Publication: 2024 Feb 09. - Publication Year :
- 2024
-
Abstract
- Objective: To evaluate whether laser-mediated assisted hatching (AH) performed on vitrified/warmed blastocysts before embryo transfer can improve live birth rate.<br />Design: The "pArtiaL zonA pelluciDa removal by assisteD hatchINg of blastocysts (ALADDIN)" is a 2-center comparative study with a parallel randomized controlled design.<br />Setting: University hospital.<br />Patients: Participants were recruited between September 2018 and November 2021. They were aged 18-39 years, underwent nondonor in vitro fertilization cycles, and were scheduled for elective single embryo transfer with vitrified/warmed blastocysts. Those with uterine abnormalities, body mass index of >35 kg/m <superscript>2</superscript> , severe male factor infertility, or performing preimplantation genetic testing were excluded.<br />Intervention: Assisted hatching was performed using a 1,480 nm diode laser, removing approximately one-third of the zona pellucida with continuous 0.2 ms pulses applied from the 1-5 o'clock positions.<br />Main Outcome Measures: The primary outcome was the live birth rate. Secondary end points included clinical pregnancy, miscarriage, multiple pregnancies, preterm births, obstetric and neonatal complications, and congenital anomalies.<br />Results: Overall, 698 participants met the inclusion criteria and were randomized: 352 patients were assigned to the AH arm and 346 to the control arm. Of the participants, 105 (29.8%) and 101 (29.2%), respectively, achieved a live birth after treatment. The relative risk of live birth in patients with vitrified/warmed blastocysts treated with AH was 1.02 (95% confidence interval, 0.86-1.19). Exploratory subgroup analyses for women's age, recruiting centers, indications for in vitro fertilization, method of insemination, blastocyst quality, and days of blastocyst development failed to highlight any clinical situation that could benefit from AH in thawed blastocysts.<br />Conclusion: In patients undergoing frozen embryo transfer with vitrified/warmed blastocysts, laser AH does not improve the live birth rate. Further studies are required to rule out milder but potentially interesting benefits in specific subgroups of patients.<br />Trial Registration: ClinicalTrials.gov: NCT03623659.<br />Competing Interests: Declaration of Interests E.P. reported grants and personal fees from MSD, grants from Ferring, IBSA, TEVA, and Gedeon Richter, grants and personal fees from Merck. P.V. received honoraria for editorial engagements. E.S. received honoraria for presentations at meetings from IBSA and Gedeon Richter, and also is handling 2 research grants from Ferring and IBSA. A.A. has nothing to disclose. M.R. has nothing to disclose. C.G. has nothing to disclose. V.B. has nothing to disclose. G.B. has nothing to disclose. M.P. has nothing to disclose. E.R. has nothing to disclose. S.F. has nothing to disclose. A.P. has nothing to disclose.<br /> (Copyright © 2024 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Humans
Female
Adult
Pregnancy
Cryopreservation methods
Zona Pellucida
Young Adult
Fertilization in Vitro methods
Infertility therapy
Infertility physiopathology
Infertility diagnosis
Adolescent
Embryo Transfer methods
Embryo Transfer adverse effects
Treatment Outcome
Embryo Culture Techniques
Single Embryo Transfer methods
Single Embryo Transfer adverse effects
Lasers
Male
Blastocyst
Vitrification
Pregnancy Rate
Live Birth
Subjects
Details
- Language :
- English
- ISSN :
- 1556-5653
- Volume :
- 122
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Fertility and sterility
- Publication Type :
- Academic Journal
- Accession number :
- 38342371
- Full Text :
- https://doi.org/10.1016/j.fertnstert.2024.02.010