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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rFSH | Active Comparator | Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. |
|
| HP-HMG | Active Comparator | Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COS with GnRH antagonists and rFSH | Drug | Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernesto Bosch, MDPhD | IVI VALENCIA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVI Valencia | Valencia | 46015 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38037188 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | rFSH | Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. COS with GnRH antagonists and rFSH: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. |
| FG001 | HP-HMG | Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function. COS with GnRH antagonists and HP-HMG: Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | rFSH | Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. COS with GnRH antagonists and rFSH: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. |
| BG001 | HP-HMG |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | ng/mL | 21 days |
|
21 Days
Coagulation panel alteration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rFSH | Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. COS with GnRH antagonists and rFSH: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COAGULATION PANEL ALTERATION | Blood and lymphatic system disorders | Vitamin K Deficiency | Non-systematic Assessment | PT: 15,4 seg; INR: 1,3; Quick Index: 69%; TTPA: 38 seg. Hemmatic parameters at minimum normal limits She was reffered to hemathologist department. There was not more information about patient since january 2018. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR. ERNESTO BOSCH | IVIValencia | +34 963050900 | Ernesto.Bosch@ivirma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2015 | Dec 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| COS with GnRH antagonists and HP-HMG | Drug | Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function. |
|
|
| Withdrawal by Subject |
|
| EXCLUDED FROM DONNOR PROGRAM |
|
Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function. COS with GnRH antagonists and HP-HMG: Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
|
| Primary | OVARIAN RESPONSE | NUMBER OF FOLICLES REACHED AND PUNCTURED AFTER CONTROLED OVARIAN STIMULATION | Posted | Mean | 95% Confidence Interval | folicles | 21 days |
|
|
|
|
| 0 |
| 56 |
| 1 |
| 56 |
| 0 |
| 56 |
| EG001 | HP-HMG | Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function. COS with GnRH antagonists and HP-HMG: Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function. | 0 | 56 | 0 | 56 | 0 | 56 |
|
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