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

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ClinicalTrials.gov Identifier: NCT01765322
Recruitment Status : Unknown
Verified November 2013 by Shi Wenhao, Shanxi Provincial Maternity and Children's Hospital.
Recruitment status was:  Recruiting
First Posted : January 10, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):

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
Female Urogenital Diseases Device: ZILOS-TK IVOS Analyzer

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  (Clinical Trial)
Estimated 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 : November 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

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 [ Time Frame: 30 days ]
    the implantation rate per embryo in first fresh embryos transfer cycles


Secondary Outcome Measures :
  1. The miscarriage [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 46 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013