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

Not Applicable

• Conditions: Female Urogenital Diseases
• Interventions: Device: ZILOS-TK IVOS Analyzer

• Registration Number: NCT01765322
• Lead Sponsor: Shanxi Provincial Maternity and Children's Hospital

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

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 Timeline

• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-10
• Status Verified: 2013-11
• Study Start: 2013-11
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-27
• Primary Completion: 2015-01
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Assisted hatching group (AH group)	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 IVOS Analyzer,Hamilton Thorne Biosciences,USA).

Primary Outcome Measures

Name	Time	Method
The implantation rate	30 days	the implantation rate per embryo in first fresh embryos transfer cycles

Secondary Outcome Measures

Name	Time	Method
The miscarriage	24 weeks

Trial Locations

Locations (1)

Maternal and Children Health Care Hospital; 🇨🇳 Xi'an, Shaanxi, China