Complications Associated With Artificial Fertilization, Placenta; Implantation, Pregnancy
Conditions
Keywords
In Vitro Fertilization, Vitrification, Frozen Embryo, Assisted Hatching, Pregnancy Rate
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.
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.
Interventions
DEVICEMechanical 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.
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| delivery rate | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| implantation rate | 1 month |
| clinical pregnancy rate | 2 months |
Other
| Measure | Time frame |
|---|---|
| multifetal pregnancy | 2 months |
Countries
Israel
Outcome results
None listed