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Trial record 23 of 415 for:    shaare zedek

Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome (VitHatSZMC)

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ClinicalTrials.gov Identifier: NCT02124291
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : April 28, 2014
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Volodarsky-Perel Alexander, MD, Shaare Zedek Medical Center

Brief Summary:
The objective of study is to assess the possible impact of assisted hatching on the implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human embryos.

Condition or disease Intervention/treatment Phase
Complications Associated With Artificial Fertilization Placenta; Implantation Pregnancy Device: Mechanical Assisted Hatching Not Applicable

Detailed Description:

The embryo implantation rate in assisted reproduction procedures is 20%, which leads to a low clinical pregnancy rate (35%), and even lower live birth rate (25%), per cycle started. Low embryo quality, poor endometrial receptivity, difficulties during the blastocyst hatching process are frequently denoted as the main reasons for the low implantation rate in humans.

The artificial rupture or thinning of the zona pellucida before embryo transfer—assisted hatching (AH)—has been proposed to foster spontaneous hatching and improve embryo implantation rates. Despite great effort, the clinical relevance of AH remains controversial and elusive.

There is a great importance of AH during frozen embryo cycles. Due to previous studies there is no precise answer about the value of AH performed on cryopreserved-thawed embryos. As far as is known, there is no clinical data to indicate the effects of AH on vitrified-warmed embryo transfer.

The objective of this prospective study is to assess the possible impact of assisted hatching on the implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human embryos.

Eligibility criteria: women age 18-42, cleavage-stage embryo transfer, less than seven IVF cycles with fresh embryo transfer, high quality embryos.

Procedure: mechanical Assisted Hatching

Primary Outcome: delivery rate Secondary Outcome: implantation rate, pregnancy rate and delivery rate.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome
Study Start Date : June 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Arm Intervention/treatment
No Intervention: No Assisted Hatching
No Assisted Hatching
Active Comparator: Assisted Hatching
Mechanical Assisted Hatching - artificial rupture of the embryo external glycoprotein layer (Zona Pellucida) before embryo transfer.
Device: Mechanical Assisted Hatching
The technique of assisted hatching using partial zona pellucida dissection to create an artificial opening of the zona pellucida of early cleaved embryos. While the embryo is stabilized by a holding pipette of micromanipulator, the zona pellucida is pierced with a microneedle that is pushed tangentially through the space between the zona pellucida and blastomeres until it pierces through the zona pellucida again.




Primary Outcome Measures :
  1. delivery rate [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. implantation rate [ Time Frame: 1 month ]
  2. clinical pregnancy rate [ Time Frame: 2 months ]

Other Outcome Measures:
  1. multifetal pregnancy [ Time Frame: 2 months ]


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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women age 18-42,
  • cleavage-stage embryo transfer,
  • less than seven IVF cycles with fresh embryo transfer,
  • high quality embryos.

Exclusion Criteria:

  • out of 18-42 y.o.
  • blastocyst embryo transfer
  • more or equal to seven IVF cycles with fresh embryo transfer
  • low quality embryos

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): NCT02124291


Locations
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Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 3235
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Alexander Volodarsky-Perel, MD Shaare Zedek Medical Center, Jerusalem, Israel.
Study Chair: Avi Tsafrir, MD Shaare Zedek Medical Center, Jerusalem, Israel

Publications:

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Responsible Party: Volodarsky-Perel Alexander, MD, MD, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02124291     History of Changes
Other Study ID Numbers: VitHatSZMC
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Keywords provided by Volodarsky-Perel Alexander, MD, Shaare Zedek Medical Center:
In Vitro Fertilization
Vitrification
Frozen Embryo
Assisted Hatching
Pregnancy Rate