Oocytes Vitrified at Prophase-I StageNCT03416400
Comparison of Vitrification Effect Before or After In Vitro Maturation
An observational study of Oocytes Vitrified at Prophase-I Stage and Oocytes Matured in Vitro, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Human oocyte cryopreservation is routinely used for fertility preservation of women who will be exposed to gonadotoxic effect of cancer treatment. After ovarian stimulation, matured oocytes are vitrified. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oocytes Vitrified at Prophase-I Stage, Oocytes Matured in Vitro
- What is being tested?
- Oocyte vitrification
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 31 Dec 2019
- 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
- Healthy volunteers accepted
- Adult
Study population: female
Who may be able to join
- - ICSI treatment
- Immature oocytes
- < 37 years old
Who cannot join
- - Polyckistic Ovarian Syndrome
- Endometriosis
- Ovulatory disease
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Florence BRUGNON
About this study
Official title: Characterization of a Method of Fertility Preservation for Patients Diagnosed for a Cancer
Human oocyte cryopreservation is routinely used for fertility preservation of women who will be exposed to gonadotoxic effect of cancer treatment. After ovarian stimulation, matured oocytes are vitrified. However, this strategy cannot always be used, particularly for hormone-sensitive cancer or when ovarian stimulation is not possible. An approach including immature oocytes and in vitro maturation (IVM) could be considered in these cases. While some qualitative analysis of oocytes vitrified before or after IVM suggest that vitrification should be performed after IVM, little is known about vitrification effects on actin and tubulin cytoskeleton and kinetic of maturation of human ovocytes.
To answer to this question, Investigator performed quantitive analyses comparing matured oocytes from three different groups: vitrified before IVM or after IVM and non-vitrified oocytes. Non-vitrified matured oocytes were used as a control. Different parameters have been analysed during maturation and in matured oocytes.
Read the detailed description
Immature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system ("Vitrolife"). Kinetic of maturation were analyzed by Primovision ("Vitrolife") and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis.
- Being tested
- Oocyte vitrification
- Keywords
- Vitrification, In vitro maturation, Cytoskeleton, chromosomes, High resolution imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte vitrificationOther
Immature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system (Vitrolife). Kinetic of maturation were analyzed by Primovision (Vitrolife) and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis.
| Study group | Role | What they receive |
|---|---|---|
| Immature oocytes vitrified before In Vitro Maturation | Immature oocytes were vitrified using closed system vitrification. After warming, they were cultured during 36 hours in IVM medium and fixed for cellular analysis Receives: Other: Oocyte vitrification | |
| Immature oocytes cultured in vitro before vitrification | Immature oocytes were cultured in vitro in IVM medium during 36 hours. After IVM, they were vitrified. After warming, they were fixed for cellular analysis. Receives: Other: Oocyte vitrification | |
| Fresh oocytes | Immature oocytes were cultured in vitro in IVM medium during 36 hours and subsequently, fixed for cellular analysis. Receives: Other: Oocyte vitrification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of maturation kinetic of oocytes vitrified at Prophase-I stage compared to fresh oocytes
After oocytes retrieval, immature oocytes will be vitrified (Rapid Vit Ovocyte®, Vitrolife) in a closed system (Rapid-I®, Vitrolife) and thawed for in vitro maturation few days after. The meiotic process will be analyzed by time lapse technology (Primovision®, Vitrolife). This will permit to score the time of maturation from resumption to polar body extrusion of ovocytes.
Measured: at day 1
Secondary outcomes (4)
Analysis of actin and tubulin cytoskeleton at Metaphase-II stage
Metaphase-II stage oocytes from both protocols 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 quantifying. The actin network and chromosomes will be analyzed quantitatively. All measurements will be compared with fresh Metaphase-II oocytes used as a control group.
Measured: at day 1
Analysis of chromosome segregation during the first meiotic division.
The first asymmetric division is highly error prone. To investigate whether chromosomes are segregated accurately after vitrification, we will perform Fluorescence In Situ Hybridization to paint each chromosome after chromosome spread from Metaphase-II stage oocytes from both conditions
Measured: at day 1
Analysis of cortical granules distribution in Metaphase-II stage oocytes.
A staining with Lectin will be used to mark cortical granules of matured oocytes from both protocols to observe whether the vitrification does modify their spatial distribution. To analyze this staining, we will use quantitative image analysis method.
Measured: at day 1
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. To know if the stock of maternal factors is diminished by the vitrification procedure, we will perform Reverse Transcription combined with Real Time PCR to quantify transcript amounts of candidates genes selected from human oocytes databases.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Jan 2017
- Primary completion1 Jan 2018
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocytes Vitrified at Prophase-I StageStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Origio A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416400
- Sponsor's protocol ID
- CHU-372
- Status last verified
- Jan 2018
- First submitted
- 24 Jan 2018
- Last updated
- 1 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of a Method of Fertility Preservation for Patients Diagnosed for a Cancer
- ClinicalTrials.gov ID
- NCT03416400
- Acronym / sponsor ID
- CHU-372
- Keywords
- Vitrification, In vitro maturation, Cytoskeleton, chromosomes, High resolution imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Origio A/S
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 31 Jan 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.
Human oocyte cryopreservation is routinely used for fertility preservation of women who will be exposed to gonadotoxic effect of cancer treatment. After ovarian stimulation, matured oocytes are vitrified. However, this strategy cannot always be used, particularly for hormone-sensitive cancer or when ovarian stimulation is not possible. An approach including immature oocytes and in vitro maturation (IVM) could be considered in these cases. While some qualitative analysis of oocytes vitrified before or after IVM suggest that vitrification should be performed after IVM, little is known about vitrification effects on actin and tubulin cytoskeleton and kinetic of maturation of human ovocytes.
To answer to this question, Investigator performed quantitive analyses comparing matured oocytes from three different groups: vitrified before IVM or after IVM and non-vitrified oocytes. Non-vitrified matured oocytes were used as a control. Different parameters have been analysed during maturation and in matured oocytes.
Detailed description
Immature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system ("Vitrolife"). Kinetic of maturation were analyzed by Primovision ("Vitrolife") and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immature oocytes vitrified before In Vitro Maturation | – | Other: Oocyte vitrificationImmature oocytes were vitrified using closed system vitrification. After warming, they were cultured during 36 hours in IVM medium and fixed for cellular analysis |
| Immature oocytes cultured in vitro before vitrification | – | Other: Oocyte vitrificationImmature oocytes were cultured in vitro in IVM medium during 36 hours. After IVM, they were vitrified. After warming, they were fixed for cellular analysis. |
| Fresh oocytes | – | Other: Oocyte vitrificationImmature oocytes were cultured in vitro in IVM medium during 36 hours and subsequently, fixed for cellular analysis. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- female
Key inclusion criteria (3 listed)
- - ICSI treatment
- Immature oocytes
- < 37 years old
Key exclusion criteria (3 listed)
- - Polyckistic 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 |
|---|---|---|
| Oocyte vitrificationImmature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system (Vitrolife). Kinetic of maturation were analyzed by Primovision (Vitrolife) and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis. | Other | Fresh oocytes, Immature oocytes cultured in vitro before vitrification, Immature oocytes vitrified before In Vitro Maturation |
Primary outcome
Analysis of maturation kinetic of oocytes vitrified at Prophase-I stage compared to fresh oocytes
Time frame: at day 1
After oocytes retrieval, immature oocytes will be vitrified (Rapid Vit Ovocyte®, Vitrolife) in a closed system (Rapid-I®, Vitrolife) and thawed for in vitro maturation few days after. The meiotic process will be analyzed by time lapse technology (Primovision®, Vitrolife). This will permit to score the time of maturation from resumption to polar body extrusion of ovocytes.
4 secondary outcomes
Analysis of actin and tubulin cytoskeleton at Metaphase-II stage
Time frame: at day 1
Analysis of chromosome segregation during the first meiotic division.
Time frame: at day 1
Analysis of cortical granules distribution in Metaphase-II stage oocytes.
Time frame: at day 1
Analysis of maternal factor stabilities.
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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.
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 Oocytes Vitrified at Prophase-I Stage and Oocytes Matured in Vitro, 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 1 Feb 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of maturation kinetic of oocytes vitrified at Prophase-I stage compared to fresh oocytes (time frame: at day 1). 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 1 Feb 2018.