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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001082 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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Excess maternal weight, especially obesity, influences almost every aspect of fertility, from conception to problems during pregnancy. The investigators will use novel statistical methods to clarify the hormonal changes behind reproductive health conditions. A better understanding of reproductive hormonal changes in obese women may offer a way to identify new treatments.
Hypothesis. Insufficient FSH (Follicle-stimulating hormone) pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production.
AIM: To test the hypothesis that insufficient FSH pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production. The investigators will determine if exogenous FSH administered in a pulsatile fashion results in a significant increase of ovarian hormones in obese women. Serial inhibin B and E2 levels will be measured in obese and normal weight women undergoing frequent blood sampling studies before and after GnRH (Gonadotropin-releasing hormone) antagonist blockade.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frequent Blood Sampling, Degarelix | Experimental | Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product. |
|
| Frequent Blood Sampling, Cetrorelix | Experimental | Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix (GnRH antagonist) | Drug | Day-1: Blood samples will be obtained every 10 minutes for 10 hours. After 10 hours of blood samples have been collected, the GnRH antagonist degarelix will be given subcutaneously. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Peak Inhibin B | This is defined as the maximum hormone value during Day 1 of the study subtracted from the maximum hormone value during Day 2. | Every 10 minutes over 2 10-hour frequent blood sampling sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Inhibin B Per Subject | Peak inhibin B will be measured every 10 minutes during day 1 and day 2 of the study. The highest inhibin B value will be defined as the peak. | Every 10 minutes over 10 hours on Day 1 and Day 2 of the study. |
| Peak E2 Per Subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Polotsky, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Clinical and Translational Research Center | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37276947 | Derived | Luu TH, Kuhn K, Bradford AP, Wempe MF, Wittenburg L, Johnson RL, Carlson NE, Kumar TR, Polotsky AJ. Effects of pulsatile intravenous follicle-stimulating hormone treatment on ovarian function in women with obesity. Fertil Steril. 2023 Oct;120(4):890-898. doi: 10.1016/j.fertnstert.2023.05.170. Epub 2023 Jun 3. |
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Some participants were excluded after signing the consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Frequent Blood Sampling, Degarelix | Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product. |
| FG001 | Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight | Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period. Normal weight participants = 18.5 to 24.9 BMI |
| FG002 | Experimental: Frequent Blood Sampling, Cetrorelix: Obese | Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period. Obese participants = BMI of >30 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Frequent Blood Sampling, Degarelix | Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product. BMI = 18.5 to 24.9 BMI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Difference Between Peak Inhibin B | This is defined as the maximum hormone value during Day 1 of the study subtracted from the maximum hormone value during Day 2. | The Degarelix arm is excluded because no data was collected from those participants. The Degarelix arm was terminated due to adverse events and was replaced with the Cetrorelix arm. | Posted | Mean | Standard Deviation | picograms/mL | Every 10 minutes over 2 10-hour frequent blood sampling sessions. |
|
7 Days
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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 | Experimental: Frequent Blood Sampling, Degarelix | Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product. BMI = 18.5 to 24.9 BMI |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delay of menses | Reproductive system and breast disorders | Non-systematic Assessment |
The Degarelix arm is excluded from outcome measure data because no usable data could be collected from those normal weight participants. There were no participants in this arm that were of high BMI. The Degarelix arm was terminated due to adverse events and was replaced with the Cetrorelix arm.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alex Polotsky | University of Colorado School of Medicine | 303-704-8221 | ALEX.POLOTSKY@CUANSCHUTZ.EDU |
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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 | Oct 6, 2020 | Jan 11, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 8, 2021 | Jan 11, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| C062876 | cetrorelix |
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| recombinant FSH | Drug | Day-2: Blood samples will again be obtained every 10 minutes for 10 hours. Repeated boluses of exogenous recombinant FSH (rFSH) will be given by IV during this 10 hour visit. |
|
|
| Cetrorelix | Drug | Day-1: Blood samples will be obtained every 10 minutes for 10 hours. After 10 hours of blood samples have been collected, the GnRH antagonist Cetrorelix will be given subcutaneously. |
|
|
E2 will be measured every 10 minutes on Day 1 and Day 2 of the study. The highest E2 value will be designated as the peak E2 value. |
| Every 10 minutes over 10 hours of Day 1 and Day 2 of the study. |
| BG001 |
| Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight |
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period. Normal weight participants = 18.5 to 24.9 BMI |
| BG002 | Experimental: Frequent Blood Sampling, Cetrorelix: Obese | Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period. Obese participants = BMI of >30 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Weight | Mean | Standard Deviation | kg |
|
| Experimental: Frequent Blood Sampling, Cetrorelix: Obese |
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period. Obese participants = BMI of >30 |
|
|
| Secondary | Peak Inhibin B Per Subject | Peak inhibin B will be measured every 10 minutes during day 1 and day 2 of the study. The highest inhibin B value will be defined as the peak. | The Degarelix arm is excluded because no data was collected from those participants. The Degarelix arm was terminated due to adverse events and was replaced with the Cetrorelix arm. | Posted | Mean | Standard Deviation | picograms/mL | Every 10 minutes over 10 hours on Day 1 and Day 2 of the study. |
|
|
|
| Secondary | Peak E2 Per Subject | E2 will be measured every 10 minutes on Day 1 and Day 2 of the study. The highest E2 value will be designated as the peak E2 value. | The Degarelix arm is excluded because no data was collected from those participants. The Degarelix arm was terminated due to adverse events and was replaced with the Cetrorelix arm. | Posted | Mean | Standard Deviation | pg/L | Every 10 minutes over 10 hours of Day 1 and Day 2 of the study. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Experimental: Frequent Blood Sampling, Cetrorelix: Normal Weight | Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period. Normal weight participants = 18.5 to 24.9 BMI | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Experimental: Frequent Blood Sampling, Cetrorelix: Obese | Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period. Obese participants = BMI of >30 | 0 | 27 | 0 | 27 | 0 | 27 |
| Hot flashes | Reproductive system and breast disorders | Non-systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |