Laser assisted hatching
ProcedureAfter warming, blastocysts are subjected to laser assisted hatching (LAH) following the standard procedure.The LAH procedure lasts one minute per blastocyst.
NCT Number: NCT03623659
The aim of study is to assess the possible impact of assisted hatching on delivery rate after transfer of vitrified-warmed human blastocysts.
Looking for future studies?
Notify Me18 year–40 year
Female
Interventional
Not applicable
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy
Zona pellucida (ZP) manipulation, termed "assisted hatching" (AH), has been introduced in order to favor embryo hatching and ultimately improve assisted reproductive technology success but with poor proofs of safety and biological plausibility.
Vitrifying and warming of blastocysts may impair the successful hatching process of the embryo out of its ZP and its following implantation into the uterus. Theoretically, AH may facilitate the hatching process and subsequently increase implantation rates.
In this prospective randomized controlled trial (RCT), the hypothesis is to test whether the application of a partial AH to vitrified/warmed blastocysts might affect patients' delivery rate.
Patients with vitrified blastocysts will be randomized at the time of blastocyst warming to a study group (with AH) or a control group (without AH). AH will be performed at the expanded blastocyst stage using a laser technique and a laser opening will be initiated at the 1 o'clock position. Consecutive laser shots will be applied to reach the 5 o'clock position of the blastocyst. The blastocysts will then be cultured at least 2 h and subsequently transferred into the patient's uterus.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After warming, blastocysts are subjected to laser assisted hatching (LAH) following the standard procedure.The LAH procedure lasts one minute per blastocyst.
Time frame: 38 weeks after embryo transfer
Number of deliveries, that result in a live birth, per transferred blastocyst
Time frame: 6-7 weeks after transfer
the number of gestational sacs observed at echographic screening at 6 weeks of pregnancy divided by the number of transferred embryos
Time frame: 4 weeks after transfer
the ultrasonographic demonstration of an intrauterine gestational sac divided by the number of included women
Time frame: 4 week after transfer
Pregnancies failing to progress to the point of ultrasound confirmation divided by the number of women with a positive pregnancy test on blood
Time frame: 20 weeks after transfer
the ultrasonographic demonstration of an intrauterine gestational sac with fetal hearth divided by the number of included women
Time frame: 4 week after transfer
a pregnancy in which more than one fetus develops in the uterus at the same time divided by the number of women with a clinical pregnancy
Time frame: after birth; 9-10 months after transfer
condition that adversely affects women and their foetal health during delivery
Time frame: after birth, 9-10 months after transfer
birth defects, congenital disorders, congenital malformations, or congenital abnormalities, are conditions of prenatal origin that are present at birth, potentially impacting an infant's health, development and/or survival divided by the number of livebirths
IRCCS San Raffaele
Other
Does Partial Zona Pellucida Removal From Vitrified-warmed Human Blastocysts Improve Delivery Rate in IVF? A Multicentric RCT on Laser Assisted Hatching
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06659692
Genital Diseases, Infertility
Toronto, Ontario, Canada
View Trial DetailsNCT06924437
Abnormal Uterine Bleeding (AUB), Endometrial Polyp
Sohag, Egypt
View Trial DetailsNCT01511588
Adolescents, Amenorrhea
Bethesda, Maryland, United States
View Trial DetailsNCT07399535
Adnexal Diseases, Cysts
Karachi, Sindh, Pakistan
View Trial Details