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Completed

NCT Number: NCT03623659

pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser assisted hatching

Procedure

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

Primary outcomes

  1. Delivery rate

    Time frame: 38 weeks after embryo transfer

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2018
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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