pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
- Conditions
- Infertility
- Interventions
- Procedure: Laser assisted hatching
- Registration Number
- NCT03623659
- Lead Sponsor
- IRCCS San Raffaele
- Brief Summary
The aim of study is to assess the possible impact of assisted hatching on delivery rate after transfer of vitrified-warmed human blastocysts.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 700
- single embryo transfer of vitrified/warmed blastocyst (SET)
- first or second frozen IVF (with or without Intracytoplasmic Sperm Injection) cycle of blastocysts
- first or second oocyte retrieval
- Preimplantation Genetic Testing (PGT) cycle
- BMI > 35 kg/m2
- severe male factor
- abnormal uterine cavity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AH group Laser assisted hatching Subjects whose vitrified/warmed blastocysts will be subjected to the treatment of laser assisted hatching
- Primary Outcome Measures
Name Time Method Delivery rate 38 weeks after embryo transfer Number of deliveries, that result in a live birth, per transferred blastocyst
- Secondary Outcome Measures
Name Time Method Clinical Pregnancy rate 4 weeks after transfer the ultrasonographic demonstration of an intrauterine gestational sac divided by the number of included women
obstetrical and neonatal complication rate after birth; 9-10 months after transfer condition that adversely affects women and their foetal health during delivery
Implantation rate 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
Ongoing pregnancy rate 20 weeks after transfer the ultrasonographic demonstration of an intrauterine gestational sac with fetal hearth divided by the number of included women
Multiple pregnancy rate 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
congenital anomalies rate 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
Biochemical pregnancy rate 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
Trial Locations
- Locations (2)
IRCCS San Raffaele
🇮🇹Milan, Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
🇮🇹Milan, Italy