Follicular Steroid Genesis in Controlled Ovarian Stimulation
ESTEFOL
Analysis of Follicular Steroid Synthesis During Controlled Ovarian Stimulation With Recombinant FSH vs HMG in GnRH Antagonist Cycles
1 other identifier
interventional
112
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedStudy Start
First participant enrolled
October 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2018
CompletedResults Posted
Study results publicly available
March 3, 2020
CompletedMarch 3, 2020
February 1, 2020
1.7 years
April 8, 2016
December 13, 2019
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
SERUM PROGSTERONE CONCENTRATION
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.
21 days
OVARIAN RESPONSE
NUMBER OF FOLICLES REACHED AND PUNCTURED AFTER CONTROLED OVARIAN STIMULATION
21 days
Study Arms (2)
rFSH
ACTIVE COMPARATORControlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.
HP-HMG
ACTIVE COMPARATORControlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Kidney failure
- Ovarian Polyquistic syndrome
- Any systemic or metabolic disfunction that counter indicates the use of gonadotrophins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IVI Valencia
Valencia, 46015, Spain
Related Publications (1)
Bosch E, Alama P, Romero JL, Mari M, Labarta E, Pellicer A. Serum progesterone is lower in ovarian stimulation with highly purified HMG compared to recombinant FSH owing to a different regulation of follicular steroidogenesis: a randomized controlled trial. Hum Reprod. 2024 Feb 1;39(2):393-402. doi: 10.1093/humrep/dead251.
PMID: 38037188DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- DR. ERNESTO BOSCH
- Organization
- IVIValencia
Study Officials
- PRINCIPAL INVESTIGATOR
Ernesto Bosch, MDPhD
IVI VALENCIA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2016
First Posted
April 14, 2016
Study Start
October 18, 2016
Primary Completion
June 15, 2018
Study Completion
June 15, 2018
Last Updated
March 3, 2020
Results First Posted
March 3, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share