Higher Dose of Rekovelle in Oocyte Donors

NCT ID: NCT04778358

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2022-06-16

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OOCYTE DONORS

Administration of a higher dose of Rekovelle (follitropin delta) to increase the ovarian response to 17 oocytes (the optimal range being 15 to 25 oocytes) in an oocyte donor population without compromising safety and efficacy.

Group Type: EXPERIMENTAL

Follitropin Delta, Recombinant

Intervention Type: DRUG

15 µg of follitropin delta will be administered subcutaneously daily

Interventions

Follitropin Delta, Recombinant

15 µg of follitropin delta will be administered subcutaneously daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

IVI Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto Valenciano de Infertilidad

Madrid, , Spain

Countries

Spain

Other Identifiers

1901-MAD-013-JG

Identifier Type: -

Identifier Source: org_study_id