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pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts

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ClinicalTrials.gov Identifier: NCT03623659
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Alessandra Alteri, IRCCS San Raffaele

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.

Condition or disease Intervention/treatment Phase
Infertility Procedure: Laser assisted hatching Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Partial Zona Pellucida Removal From Vitrified-warmed Human Blastocysts Improve Delivery Rate in IVF? A Multicentric RCT on Laser Assisted Hatching
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

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



Primary Outcome Measures :
  1. Delivery rate [ Time Frame: 38 weeks after embryo transfer ]
    Number of deliveries, that result in a live birth, per transferred blastocyst


Secondary Outcome Measures :
  1. 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

  2. Clinical Pregnancy rate [ Time Frame: 4 weeks after transfer ]
    the ultrasonographic demonstration of an intrauterine gestational sac divided by the number of included women

  3. 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. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623659


Contacts
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Contact: Alessandra Alteri, PhD +390226434308 alteri.alessandra@hsr.it
Contact: Paola Vigano', PhD +390226436228 vigano.paola@hsr.it

Locations
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Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Recruiting
Milan, Italy, 20122
Contact: Liliana Restelli       liliana.restelli@policlinico.mi.it   
Contact: Cristina Guarneri       cristina.guarneri@policlinico.mi.it   
IRCCS San Raffaele Recruiting
Milan, Italy, 20132
Contact: Alessandra Alteri, PhD    +390226434308    alteri.alessandra@hsr.it   
Contact: Paola Vigano', PhD    +390226436228    vigano.paola@hsr.it   
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
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Principal Investigator: Alessandra Alteri, PhD IRCCS San Raffaele

Publications:
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Responsible Party: Alessandra Alteri, Principal Investigator, PhD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03623659     History of Changes
Other Study ID Numbers: ALADDIN
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alessandra Alteri, IRCCS San Raffaele:
Assisted hatching
Zona pellucida
Implantation failure
Blastocyst
Cryopreservation

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female