Clinical trial NCT02503605: Biosimilar Versus Urinary Gonadotropins
Official title: Prospective Randomized Clinical Trial to Test the Efficacy of a Biosimilar Recombinant Follicle Stimulating Hormone (FSH)vs. Urinary FSH in an Oocyte Donation Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Keywords: Biosimilar
ovarian stimulation
oocyte donor
Lead sponsor: IVI Madrid
Sponsor class: OTHER
Collaborators: name: IVI Bilbao
First posted: 2015-07-21
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of metaphase II oocytes
timeFrame: 1 day
Secondary outcomes:
measure: Days of treatment
timeFrame: 2 weeks
measure: Total dose of gonadotropins (IU)
timeFrame: 2 weeks
measure: Estradiol concentration the day of human chorionic gonadotropin (hCG) administration (picograms/mililiterl)
timeFrame: 1 day
measure: Progesterone concentration the day of hCG administration (nanograms/mililiter)
timeFrame: 1 day
measure: Fertilization rate
timeFrame: 1 day
measure: Percentage of cryopreserved embryos
timeFrame: 2 weeks
measure: Implantation rate
timeFrame: 2 weeks
measure: Cancellation rate
timeFrame: 1 week
measure: Degree of satisfaction (numbers 0-10)
timeFrame: 1 month
measure: Apoptosis rate in granulosa cells
timeFrame: 1 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IVI Madrid
Study officials:
affiliation: IVI Madrid
name: Antonio Requena, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rettenbacher M, Andersen AN, Garcia-Velasco JA, Sator M, Barri P, Lindenberg S, van der Ven K, Khalaf Y, Bentin-Ley U, Obruca A, Tews G, Schenk M, Strowitzki T, Narvekar N, Sator K, Imthurn B. A multi-centre phase 3 study comparing efficacy and safety of Bemfola((R)) versus Gonal-f((R)) in women undergoing ovarian stimulation for IVF. Reprod Biomed Online. 2015 May;30(5):504-13. doi: 10.1016/j.rbmo.2015.01.005. Epub 2015 Jan 27.
citation: Wolzt M, Gouya G, Sator M, Hemetsberger T, Irps C, Rettenbacher M, Vcelar B. Comparison of pharmacokinetic and safety profiles between Bemfola((R)) and Gonal-f((R)) after subcutaneous application. Eur J Drug Metab Pharmacokinet. 2016 Jun;41(3):259-65. doi: 10.1007/s13318-015-0257-6. Epub 2015 Jan 30.