Ovarian Tissue CryopreservationNCT04666376
Assessing the Technique of Ovarian Tissue Cryopreservation by Vitrification in Vietnam
A study testing evaluation of the effectiveness of vitrification technique on ovarian tissue quality in people with Ovarian Tissue Cryopreservation and Vitrification, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 45 years, women only
- Conditions the study is for
- Ovarian Tissue Cryopreservation, Vitrification
- What is being tested?
- evaluation of the effectiveness of vitrification technique on ovarian tissue quality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ovaries from all less than 45 year-old breast cancer patients who undergo oophorectomy by laparoscopy after treated with chemotherapy
Who cannot join
- The volume of ovaries is less than 2/3 of normal 3cm (L) x 2.5cm (H) x 1.5cm (W) ovary.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
My Duc Hospital
Ho Chi Minh City
Lan Nguyen, MSC, +84906969280, nttlan@hyvonghospital.com
Vinh Dang, MD,MCE
About this study
Official title: Vitrified Ovarian Tissue in Cancer Patients: Assessing the Technique in Vietnam
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.
Read the 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.
- Conditions
- Ovarian Tissue Cryopreservation, Vitrification
- Being tested
- evaluation of the effectiveness of vitrification technique on ovarian tissue quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of the effectiveness of vitrification technique on ovarian tissue qualityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vitrified ovarian tissue | Other | Ovarian tissue will be vitrified and warmed by Ova kit type M protocol. Receives: Other: evaluation of the effectiveness of vitrification technique on ovarian tissue quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Survivable follicle
Percentage of survivable follicles per counted follicles in one fragment
Measured: After 4 hours stained by Neutral red
Secondary outcomes (2)
Rate of Healthy follicle by histological analysis
Healthy follicles of primordial, primary, secondary follicles will be counted in one slide
Measured: Immediately after tissue stained by Hematoxylin and Eosin
The relative expression ratio ( R ) of genes in follicles
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
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Tissue CryopreservationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuong M Ho, MD, MCE, Principal investigator, Hope Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666376
- Sponsor's protocol ID
- 15/20/DD-BVMD
- Status last verified
- Nov 2020
- First submitted
- 30 Nov 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitrified Ovarian Tissue in Cancer Patients: Assessing the Technique in Vietnam
- ClinicalTrials.gov ID
- NCT04666376
- Acronym / sponsor ID
- 15/20/DD-BVMD
- Conditions
- Ovarian Tissue Cryopreservation, Vitrification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitrified ovarian tissue | Other | Other: evaluation of the effectiveness of vitrification technique on ovarian tissue qualityOvarian tissue will be vitrified and warmed by Ova kit type M protocol. |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Ovaries from all less than 45 year-old breast cancer patients who undergo oophorectomy by laparoscopy after treated with chemotherapy
Key exclusion criteria (1 listed)
- The volume of ovaries is less than 2/3 of normal 3cm (L) x 2.5cm (H) x 1.5cm (W) ovary.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluation of the effectiveness of vitrification technique on ovarian tissue qualitythere 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. | Other | Vitrified ovarian tissue |
Primary outcome
Rate of Survivable follicle
Time frame: After 4 hours stained by Neutral red
Percentage of survivable follicles per counted follicles in one fragment
2 secondary outcomes
Rate of Healthy follicle by histological analysis
Time frame: Immediately after tissue stained by Hematoxylin and Eosin
The relative expression ratio ( R ) of genes in follicles
Time frame: Immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)
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Ovarian Tissue Cryopreservation in Pre-Pubertal (OTC-Pre Pubertal)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuong M Ho, MD, MCE principal investigator
Hope Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evaluation of the effectiveness of vitrification technique on ovarian tissue quality in people with Ovarian Tissue Cryopreservation and Vitrification, run by Mỹ Đức Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lan N Nguyen, MSC (+84 906 969 280, nttlan@hyvonghospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Survivable follicle (time frame: After 4 hours stained by Neutral red). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.