Infertility, FemaleMIVODON-IINCT06103383
Second Phase of the Pilot Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women
A study testing Oocyte pick up, Oocyte in vitro maturation and Oocyte in vitro activation in people with Infertility, Female and Oocyte Maturation, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
In vitro maturation (IVM) is a technique for obtaining potentially fertilizable oocytes from immature oocytes. An oocyte must be mature both nuclearly and cytoplasmically in order to be competent in the reproductive process. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility, Female, Oocyte Maturation
- What is being tested?
- Oocyte pick up, Oocyte in vitro maturation and Oocyte in vitro activation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 28 Feb 2023to 31 Dec 2024
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
-Inclusion criteria:
Women between 18-35 years old who have belonged to the egg donation program. Donors who agree to participate in the study after informing and signing the Informed Consent.
Documented previous good response to ovarian stimulation (at least 10 total oocytes and/or 8 MII).
Donors with at least one previous donation cycle, in which all oocytes obtained were freshly fertilized.
Donors who have already done all their donation cycles allowed by law. No personal or family history of interest.
From the medical point of view:
Body mass index between 18-25 kg/m2. Normal uterus and ovaries, without organic pathology. No polycystic ovaries Antral follicle count (AFC) >12 in the sum of the two ovaries on day 2-3 of the menstrual cycle. Normal karyotype Negative screening for infectious diseases (Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency Virus and Syphilis). General analysis with hemogram, hemostasis and biochemistry with parameters within normality.
-Exclusion criteria:
Any systemic or metabolic disorder that contraindicates the use of gonadotropins.
Any medical condition that implies non-inclusion in the oocyte donation program.
Taking hormonal contraceptives within the last 3 months.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Ivi Valencia
Valencia, 46015
LAURA CARACENA, NURSE, 034963050900 ext. 11054, LAURA.CARACENA@IVIRMA.COM
About this study
In vitro maturation (IVM) is a technique for obtaining potentially fertilizable oocytes from immature oocytes. An oocyte must be mature both nuclearly and cytoplasmically in order to be competent in the reproductive process. Nuclear maturation involves an oocyte in metaphase II stage and is easily evaluated for its morphology. However, cytoplasmic maturation can only be evaluated by in vitro fertilization of that oocyte. A mature nuclear and cytoplasmic oocyte is the one capable of producing a viable embryo. This study aims to optimize the in vitro maturation (IVM) technique to achieve nuclear mature oocytes, i.e., to mature the oocytes up to the metaphase II stage. In addition, an artificial oocyte activation (AOA) will be carried out to check the cytoplasmic maturation of the oocytes, avoiding the generation of potentially viable embryos.
This study corresponds to a second phase of the pilot study for the development of this technique in our IVF laboratory. We will use all we have learned in the first phase, as well as the experience acquired, to advance in the optimization of this protocol.
The correct functioning of this IVM technique would mean a reduction in the costs of ovarian stimulation treatments, as lower doses and shorter stimulation times are required, which implies lower risks for women derived from the medication and less stress for them.
- Conditions
- Infertility, Female, Oocyte Maturation
- Being tested
- Controlled ovarian stimuation, Oocyte pick up, Oocyte in vitro maturation, Oocyte in vitro activation
- Keywords
- IN VITRO MATURATION, OOCYTE ACTIVATION, FOLLICULAR PUNCTURE, hMG-HP, OOCYTE DONNORS
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled ovarian stimuationDrug
3 days stimullation protocol using hMG-HP
Oocyte pick upProcedure or surgery
Surgical oocyte pick up without triggering
Oocyte in vitro maturationProcedure or surgery
In vitro maturation procedure
Oocyte in vitro activationProcedure or surgery
In vitro oocyte activation procedure
| Study group | Role | What they receive |
|---|---|---|
| Donors with history of optimal ovarian response | Experimental | IVIRMA Valencia donors between the ages of 18-35 years old, with normal ovarian function, with a history of optimal ovarian response (at least 10 total oocytes and/or 8 MII) and who have already completed all their donation cycles allowed by law. Receives: Drug: Controlled ovarian stimuation; Procedure: Oocyte pick up; Procedure: Oocyte in vitro maturation; Procedure: Oocyte in vitro activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte in-vitro maturation
To evaluate the rate of potentially competent oocytes (after the in vitro maturation).
Measured: 1 YEAR
Oocyte activation
To evaluate the rate of potentially competent oocytes after oocyte activation process.
Measured: 1 YEAR
Secondary outcomes (3)
Oocyte recovery rate
To evaluate Oocyte recovery rate per punctured follicle
Measured: 1 year
In vitro nuclear maturation rate
To evaluate In vitro nuclear maturation rate per punctured follicle
Measured: 1 year
Artificial oocyte activation rate.
To evaluateArtificial oocyte activation rate. per punctured follicle
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start28 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Model description
- Prospective, observational, single-center, prospective cohort pilot study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ernesto Bosch, PhD, Principal investigator, IVIRMA Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103383
- Sponsor's protocol ID
- 2109-VLC-083-EB
- Acronym
- MIVODON-II
- Status last verified
- Mar 2024
- First submitted
- 23 Oct 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Phase of the Pilot Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women
- ClinicalTrials.gov ID
- NCT06103383
- Acronym / sponsor ID
- MIVODON-II / 2109-VLC-083-EB
- Conditions
- Infertility, Female, Oocyte Maturation
- Keywords
- IN VITRO MATURATION, OOCYTE ACTIVATION, FOLLICULAR PUNCTURE, hMG-HP, OOCYTE DONNORS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Oct 2023 (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.
In vitro maturation (IVM) is a technique for obtaining potentially fertilizable oocytes from immature oocytes. An oocyte must be mature both nuclearly and cytoplasmically in order to be competent in the reproductive process. Nuclear maturation involves an oocyte in metaphase II stage and is easily evaluated for its morphology. However, cytoplasmic maturation can only be evaluated by in vitro fertilization of that oocyte. A mature nuclear and cytoplasmic oocyte is the one capable of producing a viable embryo. This study aims to optimize the in vitro maturation (IVM) technique to achieve nuclear mature oocytes, i.e., to mature the oocytes up to the metaphase II stage. In addition, an artificial oocyte activation (AOA) will be carried out to check the cytoplasmic maturation of the oocytes, avoiding the generation of potentially viable embryos.
This study corresponds to a second phase of the pilot study for the development of this technique in our IVF laboratory. We will use all we have learned in the first phase, as well as the experience acquired, to advance in the optimization of this protocol.
The correct functioning of this IVM technique would mean a reduction in the costs of ovarian stimulation treatments, as lower doses and shorter stimulation times are required, which implies lower risks for women derived from the medication and less stress for them.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, observational, single-center, prospective cohort pilot study
| Arm | Type | Receives |
|---|---|---|
| Donors with history of optimal ovarian response | Experimental | Drug: Controlled ovarian stimuation, Procedure: Oocyte pick up, Procedure: Oocyte in vitro maturation, Procedure: Oocyte in vitro activationIVIRMA Valencia donors between the ages of 18-35 years old, with normal ovarian function, with a history of optimal ovarian response (at least 10 total oocytes and/or 8 MII) and who have already completed all their donation cycles allowed by law. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Controlled ovarian stimuation3 days stimullation protocol using hMG-HP | Drug | Donors with history of optimal ovarian response |
| Oocyte pick upSurgical oocyte pick up without triggering | Procedure or surgery | Donors with history of optimal ovarian response |
| Oocyte in vitro maturationIn vitro maturation procedure | Procedure or surgery | Donors with history of optimal ovarian response |
| Oocyte in vitro activationIn vitro oocyte activation procedure | Procedure or surgery | Donors with history of optimal ovarian response |
Primary outcome
Oocyte in-vitro maturation
Time frame: 1 YEAR
To evaluate the rate of potentially competent oocytes (after the in vitro maturation).
Oocyte activation
Time frame: 1 YEAR
To evaluate the rate of potentially competent oocytes after oocyte activation process.
3 secondary outcomes
Oocyte recovery rate
Time frame: 1 year
In vitro nuclear maturation rate
Time frame: 1 year
Artificial oocyte activation rate.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Infertility, Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
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.
Ernesto Bosch, PhD principal investigator
IVIRMA Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oocyte pick up, Oocyte in vitro maturation and Oocyte in vitro activation in people with Infertility, Female and Oocyte Maturation, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Mar 2024. 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 Spain. 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 LAURA CARACENA, Msr (034 963050900 ext. 11054, laura.caracena@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oocyte in-vitro maturation (time frame: 1 YEAR). The study lists 2 primary outcomes in all. 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 12 Mar 2024.