Comparative analysis of hormone variations during ovarian stimulation with two different stimulation drugs
Phase 1
- Conditions
- Women undergoing ovarian stimulation for oocyte donationTherapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2015-005762-28-ES
- Lead Sponsor
- IVI Valencia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 110
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
. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>To adjust follicular steroid levels to ovarian response<br>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 Outcome Measures
Name Time Method Secondary end point(s): None;Timepoint(s) of evaluation of this end point: N/A