Assessing the Technique of Ovarian Tissue Cryopreservation by Vitrification in Vietnam

Mỹ Đức Hospital

Status: Unknown

Conditions: Vitrification; Ovarian Tissue Cryopreservation

Treatments: Other: evaluation of the effectiveness of vitrification technique on ovarian tissue quality

Study type: Interventional

Funder types: Other

Identifiers

NCT04666376

15/20/DD-BVMD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 estimated patients

Sex: Female

Ages: Under 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Vitrified ovarian tissue

Other group

Description:

Ovarian tissue will be vitrified and warmed by Ova kit type M protocol.

Treatment:

Other: evaluation of the effectiveness of vitrification technique on ovarian tissue quality