pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623659
• Other study ID #: ALADDIN
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Infertility

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