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Clinical Trials/NCT04666376
NCT04666376
Unknown
Not Applicable

Vitrified Ovarian Tissue in Cancer Patients: Assessing the Technique in Vietnam

Mỹ Đức Hospital1 site in 1 country43 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Tissue Cryopreservation
Sponsor
Mỹ Đức Hospital
Enrollment
43
Locations
1
Primary Endpoint
Rate of Survivable follicle
Last Updated
5 years ago

Overview

Brief Summary

Ovarian tissue cryopreservation (OTC) is a new approach on fertility preservation for young female patients with cancer. It is now used by many IVF centers in the world. However, this is the first study which OTC by vitrification is carried on and assessed the effectiveness of the technique.

Detailed Description

Ovaries from all less than 45 year-old breast cancer patients who undergo oophorectomy by laparoscopy after treated with chemotherapy will be enrolled to the study. Pieces of cortex of each patient will divide into two groups. Group 1 is fresh fragments (control group) and group 2 is vitrified group. Ovarian tissues in group 2 will be vitrified or warmed with medium and devices of Ova-kit type M (Kitazato, Japan). Cortex fragments of each group will have: * Follicle survival evaluation by Neutral red staining * Histological evaluation by Hematoxylin and Eosin staining * Evaluation relative Growth Differentiation Factor 9 (GDF-9) and Caspase-3 gene expression by real-time Polymerase chain reaction (PCR). Comparison of data collected from 2 groups will be carried on to evaluate the effectiveness of the technique before applying this technique for cancer patients in Vietnam.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
January 31, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Mỹ Đức Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Ovaries from all less than 45 year-old breast cancer patients who undergo oophorectomy by laparoscopy after treated with chemotherapy

Exclusion Criteria

  • The volume of ovaries is less than 2/3 of normal 3cm (L) x 2.5cm (H) x 1.5cm (W) ovary.

Outcomes

Primary Outcomes

Rate of Survivable follicle

Time Frame: After 4 hours stained by Neutral red

Percentage of survivable follicles per counted follicles in one fragment

Secondary Outcomes

  • Rate of Healthy follicle by histological analysis(Immediately after tissue stained by Hematoxylin and Eosin)
  • The relative expression ratio ( R ) of genes in follicles(Immediately after the intervention)

Study Sites (1)

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