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

S

Shaare Zedek Medical Center

Status

Terminated

Conditions

Complications Associated With Artificial Fertilization
Placenta; Implantation
Pregnancy

Treatments

Device: Mechanical Assisted Hatching

Study type

Interventional

Funder types

Other

Identifiers

NCT02124291
VitHatSZMC

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

Female

Ages

18 to 42 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

18 participants in 2 patient groups

No Assisted Hatching
No Intervention group
Description:
No Assisted Hatching
Assisted Hatching
Active Comparator group
Description:
Mechanical Assisted Hatching - artificial rupture of the embryo external glycoprotein layer (Zona Pellucida) before embryo transfer.
Treatment:
Device: Mechanical Assisted Hatching

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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