Female InfertilityIVMNCT03998553
Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women
A study testing IN VITRO MATURATION AND OOCYTE ACTIVATION in people with Female Infertility, 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 onlyHealthy volunteers can take part
- Conditions the study is for
- Female Infertility
- What is being tested?
- IN VITRO MATURATION AND OOCYTE ACTIVATION
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2019to 17 Dec 2019
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman aged 18-35 years who have belonged to the egg donation program.
- Donors who agree to participate in the pre-trial report and sign informed consent.
- Good previous documented response to ovarian stimulation (at least 10 oocytes total and/or 8 MII).
- Donors with at least one previous cycle of donation, in which all the oocytes obtained were fertilized in fresh
- Patients who come to their last cycle of donation allowed by law
- No personal or family medical disorders history.
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- Body mass index between 18-28 kg/m2
- Normal uterus and ovaries, without organic pathology
- Non-polycystic-looking ovaries
- Antral follicle Count (AFC) > 12 from both ovaries on day 2-3 of the menstrual cycle.
- Normal Karyotype
- Negative values of infectious diseases (hepatitis B virus, hepatitis C virus, human immunodeficiency virus and syphilis)
- Analytical with CBC, hemostasis and biochemistry with parameters within normality
Who cannot join
- Any systemic or metabolic disorder that counterindicates the use of gonadotrophins.
- Any medical condition involving non-inclusion in the oocyte donation program
- Who are taking hormonal contraceptives in the last 3 months
- Severe male Factor (Semen < 3 million)
Trial locations and contacts
1 site in 1 country.
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 one capable of producing a viable embryo. This study aims to fine-tune 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.
The aim of this study is to evaluate the response to the strategy stimulation with highly purified human menopausal gonadotropin (hMG-HP) administered for three days, in association with a standard methodology of in vitro oocyte maturation (IVM), to be performed on oocyte donors.
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
- Female Infertility
- Being tested
- IN VITRO MATURATION AND OOCYTE ACTIVATION
- Keywords
- OOCYTE ACTIVATION, IN VITRO MATURATION, OOCYTE RETRIEVAL, DONNOR, hMG-HP
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN VITRO MATURATION AND OOCYTE ACTIVATIONProcedure or surgery
This study aims to fine-tune 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of obtaining potentially competent oocytes
Number of potentially competent oocytes (after in vitro maturation and oocyte activation).
Measured: 6 months
Secondary outcomes (5)
Oocyte retrieval rate
Number of Oocyte retrieved per punctured follicle.
Measured: 6 months
Artificial oocyte activation rate.
Number of activated oocyte obtained.
Measured: 6 months
In vitro nuclear maturation rate.
Number of oocyted with matured nucleous.
Measured: 6 months
Fertilization rate
Number of Fertilized oocytes obtained in a previous cycle of fresh donation of donor versus the obtained on in vitro maturation cycle.
Measured: 6 months
Mature oocytes rate
Number of Mature oocytes obtained in of a previous cycle of fresh donation of donor versus the obtained on in vitro maturation cycle.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start15 Oct 2019
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies 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 and unicentric cohort pilot study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998553
- Sponsor's protocol ID
- 1901-VLC-006-EB
- Acronym
- IVM
- Status last verified
- Jan 2020
- First submitted
- 3 Jun 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women
- ClinicalTrials.gov ID
- NCT03998553
- Acronym / sponsor ID
- IVM / 1901-VLC-006-EB
- Conditions
- Female Infertility
- Keywords
- OOCYTE ACTIVATION, IN VITRO MATURATION, OOCYTE RETRIEVAL, DONNOR, hMG-HP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 26 Jun 2019 (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 one capable of producing a viable embryo. This study aims to fine-tune 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.
The aim of this study is to evaluate the response to the strategy stimulation with highly purified human menopausal gonadotropin (hMG-HP) administered for three days, in association with a standard methodology of in vitro oocyte maturation (IVM), to be performed on oocyte donors.
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)
- Model description
- Prospective and unicentric cohort pilot study
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Woman aged 18-35 years who have belonged to the egg donation program.
- Donors who agree to participate in the pre-trial report and sign informed consent.
- Good previous documented response to ovarian stimulation (at least 10 oocytes total and/or 8 MII).
- Donors with at least one previous cycle of donation, in which all the oocytes obtained were fertilized in fresh
- Patients who come to their last cycle of donation allowed by law
Key exclusion criteria (4 listed)
- Any systemic or metabolic disorder that counterindicates the use of gonadotrophins.
- Any medical condition involving non-inclusion in the oocyte donation program
- Who are taking hormonal contraceptives in the last 3 months
- Severe male Factor (Semen < 3 million)
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 |
|---|---|---|
| IN VITRO MATURATION AND OOCYTE ACTIVATIONThis study aims to fine-tune 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. | Procedure or surgery | – |
Primary outcome
rate of obtaining potentially competent oocytes
Time frame: 6 months
Number of potentially competent oocytes (after in vitro maturation and oocyte activation).
5 secondary outcomes
Oocyte retrieval rate
Time frame: 6 months
Artificial oocyte activation rate.
Time frame: 6 months
In vitro nuclear maturation rate.
Time frame: 6 months
Fertilization rate
Time frame: 6 months
Mature oocytes rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IN VITRO MATURATION AND OOCYTE ACTIVATION in people with Female Infertility, 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?
The sponsor lists 13 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jan 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of obtaining potentially competent oocytes (time frame: 6 months). 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 28 Jan 2020.