pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts

San Donato Group (GSD)

Status: Completed

Conditions: Infertility

Treatments: Procedure: Laser assisted hatching

Study type: Interventional

Funder types: Other

Identifiers

NCT03623659

ALADDIN

Details and patient eligibility

About

The aim of study is to assess the possible impact of assisted hatching on delivery rate after transfer of vitrified-warmed human blastocysts.

Full 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.

Enrollment: 700 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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700 participants in 2 patient groups

AH group

Active Comparator group

Description:

Subjects whose vitrified/warmed blastocysts will be subjected to the treatment of laser assisted hatching

Treatment:

Procedure: Laser assisted hatching

Control group

No Intervention group

Description:

Subjects whose vitrified/warmed blastocysts will be subjected to the same procedures except for the treatment of laser assisted hatching