Higher Dose of Rekovelle in Oocyte Donors

NCT04778358 | Completed Phase 2

• 1 other identifier: 1901-MAD-013-JG
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

IVF

Outcome Measures

Primary Outcomes (2)

• Assest the dose of 15µg of follitropin delta aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25).

  To evaluate the number of oocytes of a fixed dose of 15µg of the drug Rekovelle (follitropin delta) during the entire stimulation of oocyte donors aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25).

  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

  Evaluate with a GOLAN scale. Golan classification: Classify early or late ovarian hyperstimulation syndrome, according to clinic, ultrasound and laboratory tests Mild ovarian hyperstimulation: * Grade 1 Abdominal discomfort and bloating * Grade 2 Grade 1 + nausea, vomiting, or diarrhea. Ovaries enlarged 5-12 cm in ø Moderate Hyperstimulation: • Grade 3 Grade 2 + ultrasound signs of ascites Severe hyperstimulation: * Grade 4 Grade 3 + clinical ascites, respiratory distress, hydrothorax * Grade 5 Grade 4 and hemoconcentration, hypovolemia, impaired coagulation and renal function (oligo / anuria)

  Through the study completion, an average 1 month.

Secondary Outcomes (5)

• Number of mature oocytes

  Number of madure oocytes obtained inmediatly after the puncture in visit 5

• Duration of stimulation in days

  Number of days during the ovarian stimulation up to 20 days

• Number of blasts

  4-6 days after fertilization and before implantation in the endometrium during the treatment.

• Blast quality

  4-6 days after fertilization and before implantation in the endometrium during the treatment.

• Degree of satisfaction with the infertility treatment

  At the end of the treatment, an average 1 month.

Study Arms (1)

OOCYTE DONORS

EXPERIMENTAL

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.

Drug: Follitropin Delta, Recombinant

Interventions

Follitropin Delta, Recombinant DRUG

15 µg of follitropin delta will be administered subcutaneously daily

OOCYTE DONORS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients who meet the following criteria will not be able to participate in the clinical trial:
• Simultaneous participation in another clinical trial
• Donors diagnosed with polycystic ovary syndrome according to the Rotterdam criteria (4)
• Endometriosis level III / IV
• Family history of hereditary diseases
• Presence of abnormal karyotype
• Positive for any sexually transmitted disease

Sponsors & Collaborators

• IVI Madrid: lead

Study Sites (1)

Instituto Valenciano de Infertilidad

Madrid, 28035, Spain

Location

MeSH Terms

Interventions

follitropin delta

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Oocyte donors

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: March 3, 2021
• Study Start: September 28, 2021
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)