FindTrial
Sign In

Prospective, Randomized Open Trial to Evaluate the Efficacy of Highly Purified Urinary FSH (Fostipur®, IBSA) versus Recombinant FSH (Bemfola® Finox) in Oocyte Donors Undergoing Controlled Ovarian Stimulation Based on Receptor N680S FSH Gene Polymorphism

Prospective, Randomized Open Trial to Evaluate the Efficacy of Highly Purified Urinary FSH (Fostipur®, IBSA) versus Recombinant FSH (Bemfola® Finox) in Oocyte Donors Undergoing Controlled Ovarian Stimulation Based on Receptor N680S FSH Gene Polymorphism - Genodon Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-003779-31-ES
Enrollment
Unknown
Registered
2015-10-30
Start date
2015-12-04
Completion date
Unknown
Last updated
2015-12-22

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

Conditions

Ovarian stimulation for oocyte donation. MedDRA version: 18.1 Level: LLT Classification code 10021940 Term: Infertility, female, of unspecified origin System Organ Class: 100000004872

Interventions

Trade Name: Fostipur 75 UI, polvo y disolvente para solución inyectable Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: FOLLICLE-STIMULATING HORMONE CAS Number:

Sponsors

INSTITUTO BERNABEU
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Be considered apt to get into the oocyte donation program of Instituto Bernabeu Age between 18 and 30 years Body Mass Index over 18 and under 28 Antral follicle count greater than 9 and less than 25 (adding both ovaries) Patients starting ovarian stimulation with 225 IU of FSH Presence of both ovaries Ability to participate and comply with the study protocol Signing the written consent form 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 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Not suitable for inclusion in the oocyte donation program of Institute Bernabeu. Concurrent participation in another study

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess whether the effective use of urinary or recombinant FSH can be influenced by genotype of receptor N680S FSH Gene Polymorphism;Secondary Objective: Study the differences in stimulation intensity using recombinant and urinary FSH. Study treatment cost by genotype FSH receptor and gonadotropin used (urinary versus recombinant) Study cost by oocyte obtained by genotype FSH receptor and gonadotropin used (urinary versus recombinant);Primary end point(s): Number of cumulus-oocyte complexes obtained;Timepoint(s) of evaluation of this end point: At the end of ovarian stimulation, post-puncture—

Secondary

MeasureTime frame
Secondary end point(s): Number of metaphase II (MII) oocytes Number of useful oocytes (inseminated or microinjected) Duration of stimulation (days) FSH units obtained by oocyte FSH cost by oocyte obtained Fertilization rate;Timepoint(s) of evaluation of this end point: All (except the fertilization rate) at the end of ovarian stimulation, post-puncture Fertilization rate at 18 hours post-insemination—

Countries

Spain

Contacts

Public ContactMONTSE VIDAL

CROSSDATA

montsevidal@crossdata.es0034663825890

Outcome results

None listed

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