Does Partial Zona Pellucida Removal From Vitrified-warmed Human Blastocysts Improve Delivery Rate in IVF? A Multicentric RCT on Laser Assisted Hatching
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 700
- Locations
- 2
- Primary Endpoint
- Delivery rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Preimplantation Genetic Testing (PGT) cycle
- •BMI > 35 kg/m2
- •severe male factor
- •abnormal uterine cavity
Arms & Interventions
Control group
Subjects whose vitrified/warmed blastocysts will be subjected to the same procedures except for the treatment of laser assisted hatching
AH group
Subjects whose vitrified/warmed blastocysts will be subjected to the treatment of laser assisted hatching
Intervention: Laser assisted hatching (Procedure)
Outcomes
Primary Outcomes
Delivery rate
Time Frame: 38 weeks after embryo transfer
Number of deliveries, that result in a live birth, per transferred blastocyst
Secondary Outcomes
- Ongoing pregnancy rate(20 weeks after transfer)
- Clinical Pregnancy rate(4 weeks after transfer)
- obstetrical and neonatal complication rate(after birth; 9-10 months after transfer)
- Implantation rate(6-7 weeks after transfer)
- Multiple pregnancy rate(4 week after transfer)
- congenital anomalies rate(after birth, 9-10 months after transfer)
- Biochemical pregnancy rate(4 week after transfer)
Investigators
Alessandra Alteri
Principal Investigator, PhD
IRCCS San Raffaele