Assessing the Technique of Ovarian Tissue Cryopreservation by Vitrification in Vietnam

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

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.

Study Overview

• Status: Unknown
• Conditions: Ovarian Tissue Cryopreservation; Vitrification
• Intervention / Treatment: Other: evaluation of the effectiveness of vitrification technique on ovarian tissue quality

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.

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • My Duc Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Vitrified ovarian tissue; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mỹ Đức Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): January 31, 2022

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (ACTUAL): December 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 15/20/DD-BVMD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No