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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03623659
Other study ID # ALADDIN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2018
Est. completion date January 20, 2023

Study information

Verified date January 2023
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 information / eligibility

Status Completed
Enrollment 700
Est. completion date January 20, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Milan
Italy IRCCS San Raffaele Milan

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Alteri A, Vigano P, Maizar AA, Jovine L, Giacomini E, Rubino P. Revisiting embryo assisted hatching approaches: a systematic review of the current protocols. J Assist Reprod Genet. 2018 Mar;35(3):367-391. doi: 10.1007/s10815-018-1118-4. Epub 2018 Jan 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Delivery rate Number of deliveries, that result in a live birth, per transferred blastocyst 38 weeks after embryo transfer
Secondary Implantation rate 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
Secondary Clinical Pregnancy rate the ultrasonographic demonstration of an intrauterine gestational sac divided by the number of included women 4 weeks after transfer
Secondary Biochemical pregnancy rate 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
Secondary Ongoing pregnancy rate the ultrasonographic demonstration of an intrauterine gestational sac with fetal hearth divided by the number of included women 20 weeks after transfer
Secondary Multiple pregnancy rate 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
Secondary obstetrical and neonatal complication rate condition that adversely affects women and their foetal health during delivery after birth; 9-10 months after transfer
Secondary congenital anomalies rate 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
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