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

NCT ID: NCT01765322

Last Updated: 2013-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-07-31

Brief Summary

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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

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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

Conditions

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Female Urogenital Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

ZILOS-TK IVOS Analyzer

Intervention Type DEVICE

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)

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

35 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanxi Provincial Maternity and Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shi Wenhao

Assisted Reproductive Technology Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wenhao Shi, Master

Role: STUDY_DIRECTOR

Maternal and Children Health Care Hospital

Locations

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Maternal and Children Health Care Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Juanzi Shi, Doctor

Role: CONTACT

Phone: +86-029-87219120

Email: [email protected]

Facility Contacts

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Wenhao Shi, Master

Role: primary

Other Identifiers

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MCHC-2013-01

Identifier Type: -

Identifier Source: org_study_id