pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Laser assisted hatching
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Assisted hatching, Zona pellucida, Implantation failure, Blastocyst, Cryopreservation
Eligibility Criteria
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
Sites / Locations
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- IRCCS San Raffaele
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
AH group
Control group
Arm Description
Subjects whose vitrified/warmed blastocysts will be subjected to the treatment of laser assisted hatching
Subjects whose vitrified/warmed blastocysts will be subjected to the same procedures except for the treatment of laser assisted hatching
Outcomes
Primary Outcome Measures
Delivery rate
Number of deliveries, that result in a live birth, per transferred blastocyst
Secondary Outcome Measures
Implantation rate
the number of gestational sacs observed at echographic screening at 6 weeks of pregnancy divided by the number of transferred embryos
Clinical Pregnancy rate
the ultrasonographic demonstration of an intrauterine gestational sac divided by the number of included women
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
Ongoing pregnancy rate
the ultrasonographic demonstration of an intrauterine gestational sac with fetal hearth divided by the number of included women
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
obstetrical and neonatal complication rate
condition that adversely affects women and their foetal health during delivery
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03623659
Brief Title
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
Official Title
Does Partial Zona Pellucida Removal From Vitrified-warmed Human Blastocysts Improve Delivery Rate in IVF? A Multicentric RCT on Laser Assisted Hatching
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Assisted hatching, Zona pellucida, Implantation failure, Blastocyst, Cryopreservation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AH group
Arm Type
Active Comparator
Arm Description
Subjects whose vitrified/warmed blastocysts will be subjected to the treatment of laser assisted hatching
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Subjects whose vitrified/warmed blastocysts will be subjected to the same procedures except for the treatment of laser assisted hatching
Intervention Type
Procedure
Intervention Name(s)
Laser assisted hatching
Intervention Description
After warming, blastocysts are subjected to laser assisted hatching (LAH) following the standard procedure.The LAH procedure lasts one minute per blastocyst.
Primary Outcome Measure Information:
Title
Delivery rate
Description
Number of deliveries, that result in a live birth, per transferred blastocyst
Time Frame
38 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
Implantation rate
Description
the number of gestational sacs observed at echographic screening at 6 weeks of pregnancy divided by the number of transferred embryos
Time Frame
6-7 weeks after transfer
Title
Clinical Pregnancy rate
Description
the ultrasonographic demonstration of an intrauterine gestational sac divided by the number of included women
Time Frame
4 weeks after transfer
Title
Biochemical pregnancy rate
Description
Pregnancies failing to progress to the point of ultrasound confirmation divided by the number of women with a positive pregnancy test on blood
Time Frame
4 week after transfer
Title
Ongoing pregnancy rate
Description
the ultrasonographic demonstration of an intrauterine gestational sac with fetal hearth divided by the number of included women
Time Frame
20 weeks after transfer
Title
Multiple pregnancy rate
Description
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
Time Frame
4 week after transfer
Title
obstetrical and neonatal complication rate
Description
condition that adversely affects women and their foetal health during delivery
Time Frame
after birth; 9-10 months after transfer
Title
congenital anomalies rate
Description
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
Time Frame
after birth, 9-10 months after transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra Alteri, PhD
Organizational Affiliation
IRCCS San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
IRCCS San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
29350315
Citation
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.
Results Reference
background
PubMed Identifier
32690492
Citation
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.
Results Reference
derived
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