- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04778358
Higher Dose of Rekovelle in Oocyte Donors (REKO15)
Pilot Trial to Investigate a Higher Dose of Rekovelle in Oocyte Donors
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Madrid, Spain, 28035
- Instituto Valenciano de Infertilidad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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15 µg of follitropin delta will be administered subcutaneously daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assest the dose of 15µg of follitropin delta aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25).
Time Frame: Number of oocytes obtained inmediatly after the ovarian puncture in visit 5
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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).
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Number of oocytes obtained inmediatly after the ovarian puncture in visit 5
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Measure the incidence of ovarian hyperstimulation syndrome using15µg of follitropin delta aimed at obtaining 17 oocytes
Time Frame: Through the study completion, an average 1 month.
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Evaluate with a GOLAN scale. Golan classification: Classify early or late ovarian hyperstimulation syndrome, according to clinic, ultrasound and laboratory tests Mild ovarian hyperstimulation:
Moderate Hyperstimulation: • Grade 3 Grade 2 + ultrasound signs of ascites Severe hyperstimulation:
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Through the study completion, an average 1 month.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of mature oocytes
Time Frame: Number of madure oocytes obtained inmediatly after the puncture in visit 5
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Evaluate the number of mature oocyte
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Number of madure oocytes obtained inmediatly after the puncture in visit 5
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Duration of stimulation in days
Time Frame: Number of days during the ovarian stimulation up to 20 days
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Evaluate the duration of stimulation in days
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Number of days during the ovarian stimulation up to 20 days
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Number of blasts
Time Frame: 4-6 days after fertilization and before implantation in the endometrium during the treatment.
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Early stage of embryonic development that appears 4-6 days after fertilization and before implantation in the endometrium
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4-6 days after fertilization and before implantation in the endometrium during the treatment.
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Blast quality
Time Frame: 4-6 days after fertilization and before implantation in the endometrium during the treatment.
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Blast quality according to the Gardner scale, classification of blastocysts, where in addition to the structure of the inner cell mass (ICM) and cells of the trophectoderm, it provides a degree of expansion
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4-6 days after fertilization and before implantation in the endometrium during the treatment.
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Degree of satisfaction with the infertility treatment
Time Frame: At the end of the treatment, an average 1 month.
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Degree of satisfaction with the infertility treatment according to the EFESO, Questionnaire designed to know the degree of satisfaction of women who undergo ovarian stimulation treatment to treat their infertility questionnaire
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At the end of the treatment, an average 1 month.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1901-MAD-013-JG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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