Assessing the Technique of Ovarian Tissue Cryopreservation by Vitrification in Vietnam

Vitrification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04666376
• Other study ID #: 15/20/DD-BVMD
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2020
• Source: M? Ð?c Hospital
• Contact: Lan N Nguyen, MSC
• Phone: +84 906 969 280
• Email: nttlan[@]hyvonghospital.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 43
• Est. completion date: January 31, 2022
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Tissue Cryopreservation
• Vitrification

Intervention

Other:
• evaluation 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.

Locations

Country	Name	City	State
Vietnam	My Duc Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
M? Ð?c Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Survivable follicle	Percentage of survivable follicles per counted follicles in one fragment	After 4 hours stained by Neutral red
Secondary	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
Secondary	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