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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Shi Wenhao, Shanxi Provincial Maternity and Children's Hospital
ClinicalTrials.gov Identifier:
NCT01765322
First received: January 9, 2013
Last updated: April 20, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Female Urogenital Diseases
 Device: ZILOS-TK IVOS Analyzer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Center of Assisted Reproductive Technology

Resource links provided by NLM:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by Shanxi Provincial Maternity and Children's Hospital:

Primary Outcome Measures:
  • The implantation rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    the implantation rate per embryo in first fresh embryos transfer cycles


Secondary Outcome Measures:
  • The miscarriage [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 700
Study Start Date: January 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   35 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • the maximum age; 35y ≤age≤42y
  • the maximum FSH value; FSH≤10IU/L
  • Fresh Day 3 embryos transfer in first IVF/ICSI cycles
  • the minimum number of embryos available to be transferred; ≥one embryo

Exclusion Criteria:

  • cycles with thawed/warmed embryos biopsied for PGD/PGS.
  • cycles with oocyte donation transfer.
  • uterine abnormalities
  • the maximum number of previous unsuccessful IVF attempts; ≥1cycles(transfer cycles)
  • any cycles with the risk of OHSS, fluid in the uterine cavity, abnormal endometrium, pelvic inflammation, and other acute maternal problems.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765322

Locations
China, Shaanxi
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
  More Information

No publications provided

Responsible Party: Shi Wenhao, Assisted Reproductive Technology Center, Shanxi Provincial Maternity and Children's Hospital
ClinicalTrials.gov Identifier: NCT01765322     History of Changes
Other Study ID Numbers: MCHC-2013-01
Study First Received: January 9, 2013
Last Updated: April 20, 2013
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
United States: Food and Drug Administration

Additional relevant MeSH terms:
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013