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Completed

NCT Number: NCT02738580

Follicular Steroid Genesis in Controlled Ovarian Stimulation

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

IVI Valencia

Valencia, 46015, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COS with GnRH antagonists and rFSH

Drug

Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.

Other names: GnRH antagonists and rFSH

COS with GnRH antagonists and HP-HMG

Drug

Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function.

Other names: GnRH antagonists and HP-HMG

Primary outcomes

  1. SERUM PROGSTERONE CONCENTRATION

    Time frame: 21 days

    Compare hormonal blood serum concentrations of progesterone during ovarian stimulation implied in follicular steroidogenesis during a cycle of Controlled Ovarian Stimulation with either r-FSH or HP-HMG.

  2. OVARIAN RESPONSE

    Time frame: 21 days

    NUMBER OF FOLICLES REACHED AND PUNCTURED AFTER CONTROLED OVARIAN STIMULATION

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

Analysis of Follicular Steroid Synthesis During Controlled Ovarian Stimulation With Recombinant FSH vs HMG in GnRH Antagonist Cycles

Acronym: ESTEFOL

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2016
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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