The Effect of Laser-assisted Zona Thinning on the Implantation Rate in the Women of Advanced Age
Center of Assisted Reproductive Technology
1 other identifier
interventional
150
1 country
1
Brief Summary
The purpose of this study is to determine whether laser-assisted zona thinning improve the implantation rate of the women of advanced age in the first IVF/ICSI cycles
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedNovember 27, 2013
November 1, 2013
1.2 years
January 9, 2013
November 25, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
The implantation rate
the implantation rate per embryo in first fresh embryos transfer cycles
30 days
Secondary Outcomes (1)
The miscarriage
24 weeks
Study Arms (2)
Assisted hatching group (AH group)
EXPERIMENTALThe subjects are going to participate the treatment of assisted hatching in vitro fertilization by Zona Infrared Laser Optical System (ZILOS-TK IVOS Analyzer,Hamilton Thorne Biosciences,USA).
Control group
NO INTERVENTIONThe subjects are going to undergo the same procedure except for the treatment of assisted hatching.
Interventions
The subjects are going to participate the treatment of assisted hatching in vitro fertilization by Zona Infrared Laser Optical System (ZILOS-TK,Hamilton Thorne Biosciences,USA)
Eligibility Criteria
You may qualify if:
- Age: 35y ≤age≤46y
- Basal FSH value: FSH≤10IU/L
- Day-3 embryos transferred in the fresh IVF/ICSI cycles
- the number of embryos available to be transferred on Day-3: ≥one embryo
You may not qualify if:
- cycles with thawed/warmed embryos biopsied for PGD/PGS.
- cycles with oocyte donation transfer.
- the maximum number of previous unsuccessful IVF attempts: ≥ 3 cycles(transfer cycles)
- any cycles with the risk of OHSS, fluid in the uterine cavity, abnormal endometrium, uterine abnormalities,pelvic inflammation, and other acute maternal problems.
- One or both spouses have an abnormal karyotype (including polymorphism)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maternal and Children Health Care Hospital
Xi'an, Shaanxi, 710003, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wenhao Shi, Master
Maternal and Children Health Care Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisted Reproductive Technology Center
Study Record Dates
First Submitted
January 9, 2013
First Posted
January 10, 2013
Study Start
November 1, 2013
Primary Completion
January 1, 2015
Study Completion
July 1, 2015
Last Updated
November 27, 2013
Record last verified: 2013-11