Higher Dose of Rekovelle in Oocyte Donors (NCT04778358) | Clinical Trial Compass
CompletedPhase 2
Higher Dose of Rekovelle in Oocyte Donors
Spain40 participantsStarted 2021-09-28
Plain-language summary
Higher numbers of oocytes have not been shown to increase implantation or live newborn rates, but higher numbers of oocytes are likely to be beneficial in certain treatments. These clinical cases where a high ovarian response can be IVF cycles with genetic diagnosis, patients who need more than one pregnancy or, as in our case, oocyte donation. For this reason, and based on previous studies, investigators intend to increase the ovarian response by increasing the dose of follitropin. This clinical trial aims to evaluate high doses of Rekovelle (follitropin delta) to obtain an average of 17 oocytes in a population of oocyte donors, without affecting the health of the patients.
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:
Patients who meet the following inclusion criteria will be candidates to participate in the trial.
* Signed and dated informed consent.
* Oocyte donors between 18 and 35 years of age, both inclusive.
* Presence of at least 6 antral follicles in each ovary on the day of start of stimulation.
* Oocyte donors in their first or second donation cycle.
Exclusion criteria:
Patients who meet the following criteria will not be able to participate in the clinical trial:
* Simultaneous participation in another clinical trial
* Participation in another clinical study before inclusion in this study that could affect its objectives.
* Donors diagnosed with polycystic ovary syndrome according to the Rotterdam criteria (4)
* Endometriosis level III / IV
* Use of hormonal contraceptives (oral or vaginal) in the cycle prior to inclusion.
* Use of Estradiol Valerate for cycle synchronization in the cycle prior to inclusion.
* Family history of hereditary diseases
* Presence of abnormal karyotype
* Positive for any sexually transmitted disease
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
Assest the dose of 15µg of follitropin delta aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25).
Timeframe: Number of oocytes obtained inmediatly after the ovarian puncture in visit 5
2
Measure the incidence of ovarian hyperstimulation syndrome using15µg of follitropin delta aimed at obtaining 17 oocytes
Timeframe: Through the study completion, an average 1 month.