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 range18 Years – 35 Years

SexFEMALE

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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

What they're measuring

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

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.

Trial details

NCT IDNCT04778358

SponsorIVI Madrid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-16

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