Second Phase of the Pilot Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-don… (NCT06103383) | Clinical Trial Compass
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Second Phase of the Pilot Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women
Spain10 participantsStarted 2023-02-28
Plain-language 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.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
-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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oocyte in-vitro maturation
Timeframe: 1 YEAR
2
Oocyte activation
Timeframe: 1 YEAR
Trial details
NCT IDNCT06103383
SponsorInstituto Valenciano de Infertilidad, IVI VALENCIA