NCT03623659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

September 5, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

4.4 years

First QC Date

August 3, 2018

Last Update Submit

January 20, 2023

Conditions

Infertility

Keywords

Assisted hatchingZona pellucidaImplantation failureBlastocystCryopreservation

Outcome Measures

Primary Outcomes (1)

  • Delivery rate

    Number of deliveries, that result in a live birth, per transferred blastocyst

    38 weeks after embryo transfer

Secondary Outcomes (7)

  • Implantation rate

    6-7 weeks after transfer

  • Clinical Pregnancy rate

    4 weeks after transfer

  • Biochemical pregnancy rate

    4 week after transfer

  • Ongoing pregnancy rate

    20 weeks after transfer

  • Multiple pregnancy rate

    4 week after transfer

  • +2 more secondary outcomes

Study Arms (2)

AH group

ACTIVE COMPARATOR

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

Procedure: Laser assisted hatching

Control group

NO INTERVENTION

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

Interventions

Laser assisted hatchingPROCEDURE

After warming, blastocysts are subjected to laser assisted hatching (LAH) following the standard procedure.The LAH procedure lasts one minute per blastocyst.

AH group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Preimplantation Genetic Testing (PGT) cycle
  • BMI \> 35 kg/m2
  • severe male factor
  • abnormal uterine cavity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

IRCCS San Raffaele

Milan, 20132, Italy

Location

Related Publications (3)

  • 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.

    PMID: 29350315BACKGROUND

  • Alteri A, Reschini M, Guarneri C, Bandini V, Bertapelle G, Pinna M, Rabellotti E, Ferrari S, Papaleo E, Paffoni A, Vigano P, Somigliana E. The effect of laser-assisted hatching on vitrified/warmed blastocysts: the ALADDIN randomized controlled trial. Fertil Steril. 2024 Jul;122(1):106-113. doi: 10.1016/j.fertnstert.2024.02.010. Epub 2024 Feb 9.

    PMID: 38342371DERIVED

  • Alteri A, Guarneri C, Corti L, Restelli L, Reschini M, Giardina P, Papaleo E, Somigliana E, Vigano P, Paffoni A. ALADDIN study: does assisted hatching of vitrified/warmed blastocysts improve live birth rate? Protocol for a multicentric randomised controlled trial. BMJ Open. 2020 Jul 19;10(7):e031544. doi: 10.1136/bmjopen-2019-031544.

    PMID: 32690492DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Alessandra Alteri, PhD

    IRCCS San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD

Study Record Dates

First Submitted

August 3, 2018

First Posted

August 9, 2018

Study Start

September 5, 2018

Primary Completion

January 20, 2023

Study Completion

January 20, 2023

Last Updated

January 23, 2023

Record last verified: 2023-01

Locations

IT(2)