Follicular Steroid Genesis in Controlled Ovarian Stimulation
Condition: Infertility; Controlled Ovarian Hyperstimulation
MeSH terms: Infertility
Intervention: COS with GnRH antagonists and rFSH; COS with GnRH antagonists and HP-HMG
Intervention description: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.; Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function.
Intervention MeSH terms: Prolactin Release-Inhibiting Factors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Serum concentrations of the different hormones involved in follicular steroid genesis during
      a cycle of controlled ovarian stimulation with recombinant FSH or HMG will be compared in
      this study. Serum Progesterone (P) levels at the end of Controlled Ovarian Stimulation (i.e.
      the day of triggering) have been related to cycle outcome, in terms of ongoing pregnancy and
      live birth rates. Large cohort studies show that P levels above a certain threshold are
      associated with poorer cycle outcome. The mechanisms behind P elevation are not well
      understood yet. It has been shown that P levels are positively related to ovarian response
      and to the dose of FSH given during COS. Furthermore, it has been well documented that P
      levels at the end of stimulation are significantly higher when recombinant (r) FSH is used
      for COS when compared to HMG, either in a GnRH agonist long protocol or in a GnRH antagonist
      protocol. Some authors suggest that this finding is explained by the fact that COS with rFSH
      provides a higher oocyte yield than when hMG is given, so the higher P levels observed would
      be explained by the larger number of follicles developed when rFSH is used. On the other
      hand, other authors explain this event by a different follicular esteroidogenesis when HMG is
      used for COS compared to rFSH The hypotheisis behind this assumption is that rFSH enhances P
      synthesis from its precursor pregnenolone in the granulosa cells. This P is unable to be
      further metabolized into androgens because of the lack of 17-20 lyase in the human granulosa
      cells, and therefore is delivered into circulation. On the other hand, when HMG is given for
      COS, the ∆4 pathway is promoted, and pregnenolone will be catabolized in to
      Dehidroepiandrostenodione (DHEA), in the theca cells, and this one to Androstenodione, which
      will be finally aromatized in to estrogens. This mechanism will explain the lower P and
      higher E2 levels observed in HMG cycles in comparison to rFSH cycles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  Kidney failure

          -  Ovarian Polyquistic syndrome

          -  Any systemic or metabolic disfunction that counter indicates the use of gonadotrophins

          -  Any other reason that involves exclusion of the oocyte donation program