Comparative analysis between recombinant FSH biosimilar vs. urinary FSH in a oocyte donation program

Prospective randomized clinical trial to test the efficacy of a biosimilar recombinant FSH (Bemfola) vs. urinary FSH (Fostipur) in an oocyte donation program - Bemfola vs. Fostipur

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002214-77-ES

Enrollment

Unknown

Registered

2015-09-11

Start date

2016-05-05

Completion date

Unknown

Last updated

2016-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The proposed study is to determine the efficacy of a recombinant FSH biosimilar vs. urinary FSH in oocyte donation program

Interventions

Trade Name: Fostipur Pharmaceutical Form: Powder and solvent for solution for injection in pre-filled pen INN or Proposed INN: UROFOLLITROPIN CAS Number: 97048-13-0 Other descriptive name: UROFOLLITRO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 18-35 years who meet the criteria for entry into the program and IVI Donors are to receive gonadotropins. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Those identified for Oocyte Donation Program in IVI - Patient with a basal antral count> 20 follicles in total or 30 kg / m2 - Severe hypersensitivity to drugs with similar structure

Design outcomes

Primary

Measure	Time frame
Main Objective: Non-inferiority study of a biosimilar of recombinant FSH regarding a conventional ovarian stimulation protocol with urinaryFSH compared to the number of oocytes retrieved and the number of metaphase II oocytes;Secondary Objective: - Comparative analysis of fertilization and implantation rates - Comparative analysis of the dropout rate andcycle cancellation rate - Analysis of drug-economic impact related with the administration of a biosimilar recombinant FSH vs. urinary FSH - Evaluation of oocyte quality parameters through the following analysis: - Analysis of serum hormone profile - Analysis of the rate of apoptosis in granulosa cells - Analysis of the kinetics of embryonic development;Primary end point(s): Number of metaphase II oocytes and the percentage of apoptosis in cumulus cells obtained at each stimulation protocols;Timepoint(s) of evaluation of this end point: A month	—

Measure

Time frame

Main Objective: Non-inferiority study of a biosimilar of recombinant FSH regarding a conventional ovarian stimulation protocol with urinaryFSH compared to the number of oocytes retrieved and the number of metaphase II oocytes;Secondary Objective: - Comparative analysis of fertilization and implantation rates - Comparative analysis of the dropout rate andcycle cancellation rate - Analysis of drug-economic impact related with the administration of a biosimilar recombinant FSH vs. urinary FSH - Evaluation of oocyte quality parameters through the following analysis: - Analysis of serum hormone profile - Analysis of the rate of apoptosis in granulosa cells - Analysis of the kinetics of embryonic development;Primary end point(s): Number of metaphase II oocytes and the percentage of apoptosis in cumulus cells obtained at each stimulation protocols;Timepoint(s) of evaluation of this end point: A month

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Secondary

Measure	Time frame
Secondary end point(s): - Mean length of treatment (average number of days of treatment) - Total dose of gonadotropin - Mean levels of estradiol (pg / ml) - Mean levels of progesterone (ng / ml) - Mean fertilization rate (zygote percentage relative to the number of oocytes inseminated / microinjected) Mean percentage of vitrified embryos - Mean implantation rate (number of bags relative to the number of embryos transferred) - Media cancellation rate per cycle started (percentage of cycles interrupted for lack of response after 8 days of treatment) - Average rate of ovarian hyperstimulation syndrome (percentage of participants diagnosed with SHO) - Half of adverse events. - Embryonic development kinetics parameters;Timepoint(s) of evaluation of this end point: A month	—

Measure

Time frame

Secondary end point(s): - Mean length of treatment (average number of days of treatment) - Total dose of gonadotropin - Mean levels of estradiol (pg / ml) - Mean levels of progesterone (ng / ml) - Mean fertilization rate (zygote percentage relative to the number of oocytes inseminated / microinjected) Mean percentage of vitrified embryos - Mean implantation rate (number of bags relative to the number of embryos transferred) - Media cancellation rate per cycle started (percentage of cycles interrupted for lack of response after 8 days of treatment) - Average rate of ovarian hyperstimulation syndrome (percentage of participants diagnosed with SHO) - Half of adverse events. - Embryonic development kinetics parameters;Timepoint(s) of evaluation of this end point: A month

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Countries

Spain

Contacts

Public ContactIVI Madrid

IVI Msdrid

Maria.Cruz@ivi.es+34911802900

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026