The aim of study is to assess the possible impact of assisted hatching on delivery rate after transfer of vitrified-warmed human blastocysts.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
700
After warming, blastocysts are subjected to laser assisted hatching (LAH) following the standard procedure.The LAH procedure lasts one minute per blastocyst.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy
IRCCS San Raffaele
Milan, Italy
Delivery rate
Number of deliveries, that result in a live birth, per transferred blastocyst
Time frame: 38 weeks after embryo transfer
Implantation rate
the number of gestational sacs observed at echographic screening at 6 weeks of pregnancy divided by the number of transferred embryos
Time frame: 6-7 weeks after transfer
Clinical Pregnancy rate
the ultrasonographic demonstration of an intrauterine gestational sac divided by the number of included women
Time frame: 4 weeks after transfer
Biochemical pregnancy rate
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: 4 week after transfer
Ongoing pregnancy rate
the ultrasonographic demonstration of an intrauterine gestational sac with fetal hearth divided by the number of included women
Time frame: 20 weeks after transfer
Multiple pregnancy rate
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: 4 week after transfer
obstetrical and neonatal complication rate
condition that adversely affects women and their foetal health during delivery
Time frame: after birth; 9-10 months after transfer
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congenital anomalies rate
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
Time frame: after birth, 9-10 months after transfer