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

Shanxi Provincial Maternity and Child Health Hospital

Status: Unknown

Conditions: Female Urogenital Diseases

Treatments: Device: ZILOS-TK IVOS Analyzer

Study type: Interventional

Funder types: Other

Identifiers

NCT01765322

MCHC-2013-01

Details and patient eligibility

About

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

Full 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

Enrollment: 150 estimated patients

Sex: Female

Ages: 35 to 46 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Assisted hatching group (AH group)

Experimental group

Description:

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).

Treatment:

Device: ZILOS-TK IVOS Analyzer

Control group

No Intervention group

Description:

The subjects are going to undergo the same procedure except for the treatment of assisted hatching.