Comparative analysis of hormone variations during ovarian stimulation with two different stimulation drugs

Analysis of follicular steroid synthesis during controlled ovarian stimulation with recombinant FSH vs HMG in GnRH antagonist cycles - Follicular steroid genesis in controlled ovarian stimulation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005762-28-ES

Enrollment

110

Registered

2016-02-24

Start date

2016-04-06

Completion date

Unknown

Last updated

2018-09-24

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

Conditions

Women undergoing ovarian stimulation for oocyte donation

Interventions

Trade Name: GONAL-f Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: FOLLITROPIN ALFA CAS Number: 56832-30-5 Other descriptive name: FOLLITROPIN ALFA Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: . Women aged 18-35 . Good physical and psychological condition . Normal menstrual cycle (25-35 days) . Normal ovarian reserve defined by serum ANH010-30 pMol/L . All other criteria to fulfill by oocyte donors 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 110 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: . Kidney failure . PCO . Any systemic or metabolic disfunction that counter indicates the use of gonadotrophins . Any other reason that involves exclusion of the oocyte donation program

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare serum concentrations of the different hormones involved in follicular steroid genesis during a cycle of controlled ovarian stimulation with recombinant FSH or HMG;Secondary Objective: To define the area under the curve for each of the follicular steroids across the COS cycle with rFSH and HMG To adjust follicular steroid levels to ovarian response To identify the metabolic routes for follicular steroid genesis according to the gonadotropohin used.;Primary end point(s): Area under the curve during ovarian stimulation of E2, P4, FSH, LH, 17-OH-P, Pregnenolone, Androstenodione, Dehidroepiandrostenodione, Testosterone and Estrone;Timepoint(s) of evaluation of this end point: Stimulation days 1, 4, 6, 8 and triggering	—

Measure

Time frame

Main Objective: To compare serum concentrations of the different hormones involved in follicular steroid genesis during a cycle of controlled ovarian stimulation with recombinant FSH or HMG;Secondary Objective: To define the area under the curve for each of the follicular steroids across the COS cycle with rFSH and HMG To adjust follicular steroid levels to ovarian response To identify the metabolic routes for follicular steroid genesis according to the gonadotropohin used.;Primary end point(s): Area under the curve during ovarian stimulation of E2, P4, FSH, LH, 17-OH-P, Pregnenolone, Androstenodione, Dehidroepiandrostenodione, Testosterone and Estrone;Timepoint(s) of evaluation of this end point: Stimulation days 1, 4, 6, 8 and triggering

—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Spain

Contacts

Public ContactErnesto Bosch

IVI Valencia

Ernesto.Bosch@ivi.es

Outcome results

None listed

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