Assessing the Technique of Ovarian Tissue Cryopreservation by Vitrification in Vietnam

NCT ID: NCT04666376

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-01-31

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.

Conditions

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Ovarian Tissue Cryopreservation Vitrification

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Vitrified ovarian tissue

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

Group Type OTHER

evaluation of the effectiveness of vitrification technique on ovarian tissue quality

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.
Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mỹ Đức Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tuong M Ho, MD, MCE

Role: PRINCIPAL_INVESTIGATOR

Hope Research Center

Locations

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My Duc Hospital

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

Central Contacts

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Lan N Nguyen, MSC

Role: CONTACT

Phone: +84 906 969 280

Email: [email protected]

Dang Q Vinh, MD, MCE

Role: CONTACT

Phone: +84908225481‬

Email: [email protected]

Facility Contacts

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Lan Nguyen, MSC

Role: primary

Vinh Dang, MD,MCE

Role: backup

Other Identifiers

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15/20/DD-BVMD

Identifier Type: -

Identifier Source: org_study_id