Assessing the Technique of Ovarian Tissue Cryopreservation by Vitrification in Vietnam

Not Applicable

• Conditions: Ovarian Tissue Cryopreservation; Vitrification
• Interventions: Other: evaluation of the effectiveness of vitrification technique on ovarian tissue quality

• Registration Number: NCT04666376
• Lead Sponsor: Mỹ Đức Hospital

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.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-14
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-17
• Study Start: 2021-01-01
• Primary Completion: 2021-02-01
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitrified ovarian tissue	evaluation of the effectiveness of vitrification technique on ovarian tissue quality	Ovarian tissue will be vitrified and warmed by Ova kit type M protocol.

Primary Outcome Measures

Name	Time	Method
Rate of Survivable follicle	After 4 hours stained by Neutral red	Percentage of survivable follicles per counted follicles in one fragment

Secondary Outcome Measures

Name	Time	Method
Rate of Healthy follicle by histological analysis	Immediately after tissue stained by Hematoxylin and Eosin	Healthy follicles of primordial, primary, secondary follicles will be counted in one slide
The relative expression ratio ( R ) of genes in follicles	Immediately after the intervention	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

Trial Locations

Locations (1)

My Duc Hospital; 🇻🇳 Ho Chi Minh City, Vietnam