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

This study is currently recruiting participants.
Verified November 2013 by Shanxi Provincial Maternity and Children's Hospital
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: November 25, 2013
Last verified: November 2013
  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:


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: 150
Study Start Date: November 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (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 46 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765322

Contacts
Contact: Juanzi Shi, Doctor +86-029-87219120 shijuanzi123@126.com

Locations
China, Shaanxi
Maternal and Children Health Care Hospital Recruiting
Xi'an, Shaanxi, China, 710003
Contact: Wenhao Shi, Master    +86-029-87219120    swihao@yahoo.com   
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: November 25, 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 April 17, 2014