pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03623659|
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : December 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Procedure: Laser assisted hatching||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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
- Delivery rate [ Time Frame: 38 weeks after embryo transfer ]Number of deliveries, that result in a live birth, per transferred blastocyst
- 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
- Clinical Pregnancy rate [ Time Frame: 4 weeks after transfer ]the ultrasonographic demonstration of an intrauterine gestational sac divided by the number of included women
- 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
- 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
- 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
- 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
- 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
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
|Contact: Alessandra Alteri, PhDemail@example.com|
|Contact: Paola Vigano', PhDfirstname.lastname@example.org|
|Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico||Recruiting|
|Milan, Italy, 20122|
|Contact: Liliana Restelli email@example.com|
|Contact: Cristina Guarneri firstname.lastname@example.org|
|IRCCS San Raffaele||Recruiting|
|Milan, Italy, 20132|
|Contact: Alessandra Alteri, PhD +390226434308 email@example.com|
|Contact: Paola Vigano', PhD +390226436228 firstname.lastname@example.org|
|Principal Investigator:||Alessandra Alteri, PhD||IRCCS San Raffaele|