Assessing the Technique of Ovarian Tissue Cryopreservation by Vitrification in Vietnam
Vitrified Ovarian Tissue in Cancer Patients: Assessing the Technique in Vietnam
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2020
CompletedFirst Posted
Study publicly available on registry
December 14, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedDecember 17, 2020
November 1, 2020
1 month
November 30, 2020
December 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Survivable follicle
Percentage of survivable follicles per counted follicles in one fragment
After 4 hours stained by Neutral red
Secondary Outcomes (2)
Rate of Healthy follicle by histological analysis
Immediately after tissue stained by Hematoxylin and Eosin
The relative expression ratio ( R ) of genes in follicles
Immediately after the intervention
Study Arms (1)
Vitrified ovarian tissue
OTHEROvarian tissue will be vitrified and warmed by Ova kit type M protocol.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Ovaries from all less than 45 year-old breast cancer patients who undergo oophorectomy by laparoscopy after treated with chemotherapy
You may not qualify if:
- The volume of ovaries is less than 2/3 of normal 3cm (L) x 2.5cm (H) x 1.5cm (W) ovary.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mỹ Đức Hospitallead
Study Sites (1)
My Duc Hospital
Ho Chi Minh City, Vietnam
Study Officials
- PRINCIPAL INVESTIGATOR
Tuong M Ho, MD, MCE
Hope Research Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2020
First Posted
December 14, 2020
Study Start
January 1, 2021
Primary Completion
February 1, 2021
Study Completion
January 31, 2022
Last Updated
December 17, 2020
Record last verified: 2020-11