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

Phase 1

• Conditions: The proposed study is to determine the efficacy of a recombinant FSH biosimilar vs. urinary FSH in oocyte donation program; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2015-002214-77-ES
• Lead Sponsor: IVI Madrid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-11
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

Those identified for Oocyte Donation Program in IVI
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>metaphase II oocytes;Secondary Objective: - Comparative analysis of fertilization and implantation rates<br>- Comparative analysis of the dropout rate andcycle cancellation rate<br>- Analysis of drug-economic impact related with the administration of a biosimilar recombinant FSH vs. urinary FSH<br>- Evaluation of oocyte quality parameters through the following analysis:<br>        - Analysis of serum hormone profile<br>        - Analysis of the rate of apoptosis in granulosa cells<br>        - 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

Secondary Outcome Measures

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