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Assessing the Technique of Ovarian Tissue Cryopreservation by Vitrification in Vietnam

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04666376
Enrollment
43
Registered
2020-12-14
Start date
2021-01-01
Completion date
2022-01-31
Last updated
2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Tissue Cryopreservation, Vitrification

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.

Interventions

OTHERevaluation of the effectiveness of vitrification technique on ovarian tissue quality

there are 3 types of experiments in each group, including Follicle survival evaluation by Neutral red staining, Histological evaluation by Hematoxylin and Eosin staining, 2.4. Evaluation GDF-9 and Caspase-3 gene expression by real-time PCR.

Sponsors

Mỹ Đức Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of Survivable follicleAfter 4 hours stained by Neutral redPercentage of survivable follicles per counted follicles in one fragment

Secondary

MeasureTime frameDescription
Rate of Healthy follicle by histological analysisImmediately after tissue stained by Hematoxylin and EosinHealthy follicles of primordial, primary, secondary follicles will be counted in one slide
The relative expression ratio ( R ) of genes in folliclesImmediately after the interventionFollicles in ovarian tissue will be collected, complementary deoxyribonucleic acid (cDNA) synthesis after messenger ribonucleic acid (mRNA) purification, relative quantification PCR for detecting gene expression

Countries

Vietnam

Contacts

Primary ContactLan N Nguyen, MSC
nttlan@hyvonghospital.com+84 906 969 280
Backup ContactDang Q Vinh, MD, MCE
bsvinh.dq@myduchospital.vn+84908225481‬

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026