NCT04666376

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

December 17, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 30, 2020

Last Update Submit

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

OTHER

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

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.

Vitrified ovarian tissue

Eligibility Criteria

AgeUp to 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Vietnam

Location

Study Officials

  • Tuong M Ho, MD, MCE

    Hope Research Center

    PRINCIPAL INVESTIGATOR

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

Locations