pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts

January 20, 2023 updated by: Alessandra Alteri, IRCCS San Raffaele

Does Partial Zona Pellucida Removal From Vitrified-warmed Human Blastocysts Improve Delivery Rate in IVF? A Multicentric RCT on Laser Assisted Hatching

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • IRCCS San Raffaele
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AH group
Subjects whose vitrified/warmed blastocysts will be subjected to the treatment of laser assisted hatching
Procedure: Laser assisted hatching
After warming, blastocysts are subjected to laser assisted hatching (LAH) following the standard procedure.The LAH procedure lasts one minute per blastocyst.
No Intervention: Control group
Subjects whose vitrified/warmed blastocysts will be subjected to the same procedures except for the treatment of laser assisted hatching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery rate
Time Frame: 38 weeks after embryo transfer
Number of deliveries, that result in a live birth, per transferred blastocyst
38 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: 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
6-7 weeks after transfer
Clinical Pregnancy rate
Time Frame: 4 weeks after transfer
the ultrasonographic demonstration of an intrauterine gestational sac divided by the number of included women
4 weeks after transfer
Biochemical pregnancy rate
Time Frame: 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
4 week after transfer
Ongoing pregnancy rate
Time Frame: 20 weeks after transfer
the ultrasonographic demonstration of an intrauterine gestational sac with fetal hearth divided by the number of included women
20 weeks after transfer
Multiple pregnancy rate
Time Frame: 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
4 week after transfer
obstetrical and neonatal complication rate
Time Frame: after birth; 9-10 months after transfer
condition that adversely affects women and their foetal health during delivery
after birth; 9-10 months after transfer
congenital anomalies rate
Time Frame: 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
after birth, 9-10 months after transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Alessandra Alteri, PhD, IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2018

Primary Completion (Actual)

January 20, 2023

Study Completion (Actual)

January 20, 2023

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALADDIN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on Laser assisted hatching

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe