Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women (NCT03998553) | Clinical Trial Compass
CompletedNot Applicable
Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women
Spain10 participantsStarted 2019-10-15
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 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.
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:
* 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.
* 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
Exclusion Criteria:
* 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)
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
rate of obtaining potentially competent oocytes
Timeframe: 6 months
Trial details
NCT IDNCT03998553
SponsorInstituto Valenciano de Infertilidad, IVI VALENCIA