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

Center of Assisted Reproductive Technology

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

Study Overview

• Status: Unknown
• Conditions: Female Urogenital Diseases
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710003
      • Recruiting
      • Maternal and Children Health Care Hospital
      • Contact: Wenhao Shi, Master; Phone Number: +86-029-87219120; Email: swihao@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The implantation rate	the implantation rate per embryo in first fresh embryos transfer cycles	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The miscarriage	24 weeks

Collaborators and Investigators

• Sponsor: Shanxi Provincial Maternity and Children's Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: January 9, 2013
• First Submitted That Met QC Criteria: January 9, 2013
• First Posted (Estimate): January 10, 2013

Study Record Updates

• Last Update Posted (Estimate): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 25, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: MCHC-2013-01