Pregnancy Outcomes Clinical Trial
Official title:
Does Laser-assisted Hatching(LAH) May Improve the Pregnancy Outcomes in Human?
Verified date | June 2019 |
Source | Tang-Du Hospital |
Contact | Ming Wang |
Phone | 8613259809290 |
wangmingbio[@]snnu.edu.cn | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A defect in the hatching stage is considered an important cause of implantation failure. Therefore, assisted hatching (AH), which involves artificial disruption of the zona pellucida, has been proposed as a method for improving the capacity of the embryo to implant. But the advantage of using laser to facilitate the hatching process of embryos in ART practice is debatable, and an optimum strategy for performing LAH remains elusive. Therefore, the aim of this study was to evaluate the effects of laser-assisted hatching(LAH) on clinical outcomes. Patients were randomly divided into control and LAH groups. The zona pellucida was thinned or drilled with a diode laser. Relevant parameters are recorded to evaluate the validity of LAH in ART.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | November 1, 2019 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 22 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Patients undergoing IVF/ICSI-ET cycle; - The zone pellucida of the cleavage-stage embryo is thicker than 8 µm. Exclusion Criteria: - Number of embryos transferred per cycle >2; - The transferred embryos including fresh and frozen cycle in the same cycle; - Embryos developed from the frozen-thawed oocytes. |
Country | Name | City | State |
---|---|---|---|
China | Tangdu Hospital | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Tang-Du Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of LAH in ART | Assess the clinical pregnancy | 6 months | |
Secondary | Feasibility of LAH in ART | Incidence of LAH adverse events was assessed by miscarriage rate and multiple gestation rate. | 1 year |
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