FertilityOVOMIVNCT03680937
Methods for Fertility Preservation: Impact of Vitrification on in Vitro Matured Oocytes
An observational study of Fertility and Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
During the last decades, there was an improvement of the cancer treatments of the woman and the teenagers. Therefore higher survival rate is described. However, cancer treatments can alter the reproduction functions and reduce considerably the window of the fertility to the adulthood. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- What is being tested?
- Gavi , Merck® (automated vitrification instrument) and Vitrification
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2018to 31 Jul 2020
- Phase
- Observational
- 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 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Study population: women
Who may be able to join
- ICSI treatment
- Immature oocytes
- Without ovulation pathologies
Who cannot join
- Polykistic ovarian syndrome
- Endometriosis
- Ovulatory disease
Trial locations and contacts
1 site in 1 country.
France1 site
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
Florence BRUGNON
About this study
During the last decades, there was an improvement of the cancer treatments of the woman and the teenagers. Therefore higher survival rate is described. However, cancer treatments can alter the reproduction functions and reduce considerably the window of the fertility to the adulthood. Therefore, it is recommended to proceed to a fertility preservation by oocytes vitrification when it is possible. The vitrification is a freezing technique allowing high survival rate and similar results by assisted reproductive technologies compared with the use of fresh oocytes. An innovative method of automated vitrification was recently developed. The usual protocol consist to vitrify mature oocytes. However, this strategy cannot be used for hormone -sensitive cancer or when ovarian stimulation is not possible. In these situations, immature oocytes can be collected. It is also necessary to realize an in vitro maturation step for a use by assisted reproductive technology.
According to the recent data of the literature, it remains unclear whether the vitrification of ovocytes must be performed before or after in vitro maturation (IVM). Therefore the aim of this study is to study the impact on structure and functions of ovocytes when vitrification is performed before or after IVM. The vitrification will be performed by a semi-automatic method which is an innovative method.
Read the detailed description
To perform this study, investigator will compare three groups. Group 1: immature ovocytes vitrified before IVM; Group 2: immature oocytes vitrified after IVM; Group3: fresh immature oocytes treated by IVM (without vitrification, control group).
The immature oocytes provide from ICSI patients. In routine these oocytes (germinal vesicle) are normally destroyed because they cannot be used for injection. The women will give an informed and written consent. Inclusion criteria are women less 37 years without dysovulation.
The vitrification will be performed with the semi-automatic method (Gavi, Merck). The kinetic and maturation rate will be analysed by time lapse (Primovision, Vitrolife) In the mature oocytes, the actin and tubulin cytoskeleton, the spindle organization and the cortical granules will be studied by immunofluorescence and 3D confocal microscopy. The expression of maternal factors transcription will be analyzed by RT-PCR. The ploidy will be analysed by multiFISH and/or CGH array.
- Being tested
- Gavi , Merck® (automated vitrification instrument), Vitrification
- Keywords
- Vitrification, In vitro maturation, time lapse, High resolution imaging, quantitative molecular analysis
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gavi , Merck® (automated vitrification instrument)Other
Gavi, Merck ® permits semi-automated vitrification with closed system.
VitrificationOther
Group 1: immature ovocytes vitrified before IVM; Group 2: immature oocytes vitrified after IVM; Group3: fresh immature oocytes treated by IVM (without vitrification, control group).
| Study group | Role | What they receive |
|---|---|---|
| Immature oocytes vitrified before in vitro maturation | Immature oocytes will be vitrified using closed system vitrification with a semiautomatic method. After warming, a maturation culture will be performed during 36 hours Receives: Other: Gavi , Merck® (automated vitrification instrument); Other: Vitrification | |
| Immature oocytes vitrified after in vitro maturation | A maturation culture of immature oocytes will be performed in vitro during 36 hours. After IVM, mature oocytes will be vitrify in closed system by a semi-automatic method. Receives: Other: Gavi , Merck® (automated vitrification instrument); Other: Vitrification | |
| Fresh oocytes | The culture of immature oocytes will be performed during 36 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
The embryonic development kinetics
from the records obtained with Time Lapse Primovision, investigator will be able to determine the precise times of embryonic development after in vitro maturation.
Measured: 6 days after ICSI and through study completion
Secondary outcomes (4)
Analysis of actin and tubulin cytoskeleton and spindle organization in mature ovocytes (Metaphase II)
Metaphase-II stage oocytes will be used for Immuno-Fluorescence experiments to stain actin, tubulin and chromosomes. Oocytes will be imaged using confocal microscope to perform high resolution imaging and quantitative image analysis. The length, position and orientation of the second meiotic spindle will be analysed. The actin network and chromosomes will be analysed quantitatively. All measurements will be compared with fresh matured (Metaphase-II) oocytes used as a control group.
Measured: 01/01/2019 - 31/12/2019
Analysis of chromosome segregation during the first meiotic division
A multi Fluorescence in Situ Hybridization and/or a CGH array will be performed to measure the chromosome segregation after vitrification
Measured: 01/01/2019 - 31/12/2019
Analysis of cortical granules distribution in mature (Metaphase II) oocytes.
A staining with Lectin will be used to mark cortical granules of matured oocytes to observe whether the protocol has an impact on their spatial distribution. To analyse this staining, investigator will use quantitative image analysis method.
Measured: 01/01/2019 - 31/12/2019
Analysis of maternal factor stabilities.
Maternal factors stored in the oocyte cytoplasm during oogenesis as proteins and transcripts are essential for the early embryonic development. Investigator will perform Reverse Transcription combined with Real Time PCR to quantify transcript amounts of candidates genes selected from human oocytes databases.
Measured: 01/01/2019 - 31/12/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start20 Sep 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence BRUGNON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680937
- Sponsor's protocol ID
- CHU-393
- Acronym
- OVOMIV
- Status last verified
- Sep 2018
- First submitted
- 5 Jun 2018
- Last updated
- 21 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chaput L, Dollet S, Eymard-Pierre E, Pereira B, Lucas C, Gremeau AS, Tchirkov A, Marteil G, Brugnon F. Analysis of maturation dynamics and oocyte nuclear quality after rescue-IVM and semi-automated vitrification. Hum Reprod. 2025 Jul 1;40(7):1344-1356. doi: 10.1093/humrep/deaf078.
PubMed 40373183
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methods for Fertility Preservation: Impact of Vitrification on in Vitro Matured Oocytes
- ClinicalTrials.gov ID
- NCT03680937
- Acronym / sponsor ID
- OVOMIV / CHU-393
- Keywords
- Vitrification, In vitro maturation, time lapse, High resolution imaging, quantitative molecular analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 20 Sep 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 21 Sep 2018 (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.
During the last decades, there was an improvement of the cancer treatments of the woman and the teenagers. Therefore higher survival rate is described. However, cancer treatments can alter the reproduction functions and reduce considerably the window of the fertility to the adulthood. Therefore, it is recommended to proceed to a fertility preservation by oocytes vitrification when it is possible. The vitrification is a freezing technique allowing high survival rate and similar results by assisted reproductive technologies compared with the use of fresh oocytes. An innovative method of automated vitrification was recently developed. The usual protocol consist to vitrify mature oocytes. However, this strategy cannot be used for hormone -sensitive cancer or when ovarian stimulation is not possible. In these situations, immature oocytes can be collected. It is also necessary to realize an in vitro maturation step for a use by assisted reproductive technology.
According to the recent data of the literature, it remains unclear whether the vitrification of ovocytes must be performed before or after in vitro maturation (IVM). Therefore the aim of this study is to study the impact on structure and functions of ovocytes when vitrification is performed before or after IVM. The vitrification will be performed by a semi-automatic method which is an innovative method.
Detailed description
To perform this study, investigator will compare three groups. Group 1: immature ovocytes vitrified before IVM; Group 2: immature oocytes vitrified after IVM; Group3: fresh immature oocytes treated by IVM (without vitrification, control group).
The immature oocytes provide from ICSI patients. In routine these oocytes (germinal vesicle) are normally destroyed because they cannot be used for injection. The women will give an informed and written consent. Inclusion criteria are women less 37 years without dysovulation.
The vitrification will be performed with the semi-automatic method (Gavi, Merck). The kinetic and maturation rate will be analysed by time lapse (Primovision, Vitrolife) In the mature oocytes, the actin and tubulin cytoskeleton, the spindle organization and the cortical granules will be studied by immunofluorescence and 3D confocal microscopy. The expression of maternal factors transcription will be analyzed by RT-PCR. The ploidy will be analysed by multiFISH and/or CGH array.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immature oocytes vitrified before in vitro maturation | – | Other: Gavi , Merck® (automated vitrification instrument), Other: VitrificationImmature oocytes will be vitrified using closed system vitrification with a semiautomatic method. After warming, a maturation culture will be performed during 36 hours |
| Immature oocytes vitrified after in vitro maturation | – | Other: Gavi , Merck® (automated vitrification instrument), Other: VitrificationA maturation culture of immature oocytes will be performed in vitro during 36 hours. After IVM, mature oocytes will be vitrify in closed system by a semi-automatic method. |
| Fresh oocytes | – | –The culture of immature oocytes will be performed during 36 hours |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women
Key inclusion criteria (3 listed)
- ICSI treatment
- Immature oocytes
- Without ovulation pathologies
Key exclusion criteria (3 listed)
- Polykistic ovarian syndrome
- Endometriosis
- Ovulatory disease
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 |
|---|---|---|
| Gavi , Merck® (automated vitrification instrument)Gavi, Merck ® permits semi-automated vitrification with closed system. | Other | Immature oocytes vitrified after in vitro maturation, Immature oocytes vitrified before in vitro maturation |
| VitrificationGroup 1: immature ovocytes vitrified before IVM; Group 2: immature oocytes vitrified after IVM; Group3: fresh immature oocytes treated by IVM (without vitrification, control group). | Other | Immature oocytes vitrified after in vitro maturation, Immature oocytes vitrified before in vitro maturation |
Primary outcome
The embryonic development kinetics
Time frame: 6 days after ICSI and through study completion
from the records obtained with Time Lapse Primovision, investigator will be able to determine the precise times of embryonic development after in vitro maturation.
4 secondary outcomes
Analysis of actin and tubulin cytoskeleton and spindle organization in mature ovocytes (Metaphase II)
Time frame: 01/01/2019 - 31/12/2019
Analysis of chromosome segregation during the first meiotic division
Time frame: 01/01/2019 - 31/12/2019
Analysis of cortical granules distribution in mature (Metaphase II) oocytes.
Time frame: 01/01/2019 - 31/12/2019
Analysis of maternal factor stabilities.
Time frame: 01/01/2019 - 31/12/2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Derived from this study: PubMed 40373183Chaput L, Dollet S, Eymard-Pierre E, Pereira B, Lucas C, Gremeau AS, Tchirkov A, Marteil G, Brugnon F. Analysis of maturation dynamics and oocyte nuclear quality after rescue-IVM and semi-automated vitrification. Hum Reprod. 2025 Jul 1;40(7):1344-1356. doi: 10.1093/humrep/deaf078.
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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.
Florence BRUGNON principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility and Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 3 inclusion and 3 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 21 Sep 2018. 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 France. 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 Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The embryonic development kinetics (time frame: 6 days after ICSI and through study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03680937, which also lists 1 linked publication.
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 21 Sep 2018.