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The Effect of Laser-assisted Zona Thinning on the Implantation Rate in the Women of Advanced Age

Sponsor
Shanxi Provincial Maternity and Children's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01765322
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
19.9
Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: ZILOS-TK IVOS Analyzer
 N/A

Detailed Description

Registry procedures：

  1. It's required to sign an informed consent form prior to the recruitment of all patients.

  2. Data collection and entry need double check and supervision.

The outcome measures:

the implantation rate per embryo transfer miscarriage live birth

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Center of Assisted Reproductive Technology
Study Start Date :
Nov 1, 2013
Anticipated Primary Completion Date :
Jan 1, 2015
Anticipated Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Assisted hatching group (AH group)

The 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).

Device: ZILOS-TK IVOS Analyzer
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)
No Intervention: Control group

The subjects are going to undergo the same procedure except for the treatment of assisted hatching.

Outcome Measures

Primary Outcome Measures

  1. The implantation rate [30 days]

    the implantation rate per embryo in first fresh embryos transfer cycles

Secondary Outcome Measures

  1. The miscarriage [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 46 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maternal and Children Health Care Hospital Xi'an Shaanxi China 710003

Sponsors and Collaborators

  • Shanxi Provincial Maternity and Children's Hospital

Investigators

  • Study Director: Wenhao Shi, Master, Maternal and Children Health Care Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shi Wenhao, Assisted Reproductive Technology Center, Shanxi Provincial Maternity and Children's Hospital
ClinicalTrials.gov Identifier:
NCT01765322
Other Study ID Numbers:
  • MCHC-2013-01
First Posted:
Jan 10, 2013
Last Update Posted:
Nov 27, 2013
Last Verified:
Nov 1, 2013

Study Results

No Results Posted as of Nov 27, 2013