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

Female Urogenital Diseases Clinical Trial

Official title:

Center of Assisted Reproductive Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01765322
• Other study ID #: MCHC-2013-01
• Status: Recruiting
• Phase: N/A
• First received: January 9, 2013
• Last updated: November 25, 2013
• Start date: November 2013
• Est. completion date: July 2015

Study information

• Verified date: November 2013
• Source: Shanxi Provincial Maternity and Children's Hospital
• Contact: Juanzi Shi, Doctor
• Phone: +86-029-87219120
• Email: shijuanzi123[@]126.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of ChinaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 46 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Urogenital Diseases

Intervention

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)

Locations

Country	Name	City	State
China	Maternal and Children Health Care Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shanxi Provincial Maternity and Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The implantation rate	the implantation rate per embryo in first fresh embryos transfer cycles	30 days	Yes
Secondary	The miscarriage		24 weeks	Yes