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Second Phase of the Pilot Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women

Second Phase of the Pilot Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06103383
Acronym
MIVODON-II
Enrollment
10
Registered
2023-10-26
Start date
2023-02-28
Completion date
2024-12-31
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female, Oocyte Maturation

Keywords

IN VITRO MATURATION, OOCYTE ACTIVATION, FOLLICULAR PUNCTURE, hMG-HP, OOCYTE DONNORS

Brief 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. 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.

Interventions

DRUGControlled ovarian stimuation

3 days stimullation protocol using hMG-HP

Surgical oocyte pick up without triggering

PROCEDUREOocyte in vitro maturation

In vitro maturation procedure

PROCEDUREOocyte in vitro activation

In vitro oocyte activation procedure

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Prospective, observational, single-center, prospective cohort pilot study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

-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.

Design outcomes

Primary

MeasureTime frameDescription
Oocyte in-vitro maturation1 YEARTo evaluate the rate of potentially competent oocytes (after the in vitro maturation).
Oocyte activation1 YEARTo evaluate the rate of potentially competent oocytes after oocyte activation process.

Secondary

MeasureTime frameDescription
Oocyte recovery rate1 yearTo evaluate Oocyte recovery rate per punctured follicle
In vitro nuclear maturation rate1 yearTo evaluate In vitro nuclear maturation rate per punctured follicle
Artificial oocyte activation rate.1 yearTo evaluateArtificial oocyte activation rate. per punctured follicle

Countries

Spain

Contacts

Primary ContactLAURA CARACENA, Msr
laura.caracena@ivirma.com034 963050900
Backup ContactCRISTINA RODRIGUEZ, Mss
cristina.rodriguez@ivirma.com034 963050900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026