Assessing the Technique of Ovarian Tissue Cryopreservation by Vitrification in Vietnam

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovarian Tissue Cryopreservation, Vitrification

Intervention / Treatment
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* Other: evaluation of the effectiveness of vitrification technique on ovarian tissue quality


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vitrified ovarian tissue<br>Ovarian tissue will be vitrified and warmed by Ova kit type M protocol. | Other: evaluation of the effectiveness of vitrification technique on ovarian tissue quality<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Survivable follicle | Percentage of survivable follicles per counted follicles in one fragment | After 4 hours stained by Neutral red | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Healthy follicle by histological analysis | Healthy follicles of primordial, primary, secondary follicles will be counted in one slide | Immediately after tissue stained by Hematoxylin and Eosin | 
| The relative expression ratio ( R ) of genes in follicles | Follicles in ovarian tissue will be collected, complementary deoxyribonucleic acid (cDNA) synthesis after messenger ribonucleic acid (mRNA) purification, relative quantification PCR for detecting gene expression | Immediately after the intervention |