NCT04778358

Higher Dose of Rekovelle in Oocyte Donors

Pilot Trial to Investigate a Higher Dose of Rekovelle in Oocyte Donors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: IVI Madrid · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

IVF ovarian stimulation cycles has been shown that the individualization of the medication doses provides clinical results comparable to conventional ovarian stimulation regimens, but also it results in greater treatment safety by significantly reducing the percentage of patients with responses extreme ovaries, and cycle cancellations. These studies have been carried out with the premise that an optimal ovarian response results in obtaining 8-14 oocytes per puncture. Although it has also been shown that larger numbers of oocytes do not increase clinical variables such as implantation rates or live newborn per cycle, it is possible that these numbers of oocytes are insufficient in specific circumstances, for example, patients with a desire to have more pregnancy, patients undergoing IVF cycles with PGT-A, or gamete donors. For these reasons, and thanks to the improvements in cryopreservation programs and the induction of oocyte maturation with GnRH agonists, it is necessary to design protocols for the individualization of doses of medication aimed at obtaining greater quantities of oocytes. The objective of this pilot study is the evaluation of higher doses of Rekovelle (follitropin delta) aimed at obtaining 17 oocytes in voluntary donors.

Conditions

• IVF

Interventions

Type	Name	Description
DRUG	Follitropin Delta, Recombinant	15 µg of follitropin delta will be administered subcutaneously daily

Timeline

• Start date: 2021-09-28
• Primary completion: 2022-06-16
• Completion: 2022-06-16
• First posted: 2021-03-03
• Last updated: 2022-11-14

Locations

1 site across 1 country: Spain