Infertility
Conditions
Keywords
Biosimilar, ovarian stimulation, oocyte donor
Brief summary
Biosimilar drug marketing of recombinant FSH for the treatment of infertility is another step in simplifying fertility treatments, making them easier to manage and more accessible to patients. Taking in mind these arguments ,the study is proposed for determining equivalence in terms of biological effectiveness of an ovarian stimulation protocol with biosimilar recombinant FSH stimulation protocol vs. urinary FSH in oocyte donation program.
Detailed description
Biosimilar products are drugs like biotechnological origin to other innovative biological medicines and that can be marketed once the patent has expired. These drugs are intended to achieve the same therapeutic benefit as biological medicinal resembles. Because of the similarity in both the active substance in the formulation, it is intended to demonstrate the equivalence between the biosimilar medicine of recombinant FSH and FSH of urinary origin in terms of fitness. The investigators' main objective is to perform a non-inferiority trial of biosimilar recombinant FSH product compared to a conventional ovarian stimulation protocol with urinary FSH in relation to the number of oocytes retrieved and the number of metaphase II oocytes.
Interventions
DRUGBiosimilar recombinant FSH
Controlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH
DRUGUrinary FSH
Controlled ovarian stimulation with 150 IU/day urinary FSH
Sponsors
IVI Bilbao
IVI Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 18-35 years who meet the criteria for entry into the oocyte donor program and that are going to undergo controlled ovarian stimulation
Exclusion criteria
* Patient with a basal antral count\> 20 follicles in total or \<6 antral follicles per ovary * Patients with comorbidities that, in the opinion of the investigator, may interfere with the treatment of ovarian stimulation * The presence of ovarian cysts that judgment of the investigator would interfere with the stimulation or may pose a risk to the donor * BMI \<18 kg / m2 * BMI\> 30 kg / m2 * Severe hypersensitivity to drugs with similar structure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of metaphase II oocytes | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Total dose of gonadotropins (IU) | 2 weeks |
| Estradiol concentration the day of human chorionic gonadotropin (hCG) administration (picograms/mililiterl) | 1 day |
| Progesterone concentration the day of hCG administration (nanograms/mililiter) | 1 day |
| Fertilization rate | 1 day |
| Days of treatment | 2 weeks |
| Implantation rate | 2 weeks |
| Cancellation rate | 1 week |
| Degree of satisfaction (numbers 0-10) | 1 month |
| Apoptosis rate in granulosa cells | 1 month |
| Percentage of cryopreserved embryos | 2 weeks |
Countries
Spain
Contacts
Primary ContactAntonio Requena, MD, PhD
Backup ContactMaría Cruz, PhD
Outcome results
None listed