Infertility
Conditions
Keywords
Assisted hatching, Zona pellucida, Implantation failure, Blastocyst, Cryopreservation
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.
Interventions
PROCEDURELaser assisted hatching
After warming, blastocysts are subjected to laser assisted hatching (LAH) following the standard procedure.The LAH procedure lasts one minute per blastocyst.
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivery rate | 38 weeks after embryo transfer | Number of deliveries, that result in a live birth, per transferred blastocyst |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy rate | 4 weeks after transfer | the ultrasonographic demonstration of an intrauterine gestational sac divided by the number of included women |
| 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 |
| 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 |
| 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 |
| obstetrical and neonatal complication rate | after birth; 9-10 months after transfer | condition that adversely affects women and their foetal health during delivery |
| 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 |
| 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 |
Countries
Italy
Outcome results
None listed