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Clinical Trials/EUCTR2015-002214-77-ES
EUCTR2015-002214-77-ES
Active, not recruiting
Phase 1

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

IVI Madrid0 sitesSeptember 11, 2015
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ConditionsThe proposed study is to determine the efficacy of a recombinant FSH biosimilar vs. urinary FSH in oocyte donation programTherapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
DrugsFostipurBemfola

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
The proposed study is to determine the efficacy of a recombinant FSH biosimilar vs. urinary FSH in oocyte donation program
Sponsor
IVI Madrid
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 11, 2015
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
IVI Madrid

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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