Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414096
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-10
Brief Title:
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypothesis The investigators hypothesize that pulsatile FSH intravenous administration to women with obesity will correct the Reprometabolic Syndrome RMS luteal deficiency phenotype
Specific Aim To test the hypothesis that pulsatile IV administration of FSH will rescue the impaired folliculogenesis and relative hypogonadotropic hypogonadism characteristic of obesity The investigators will accomplish this by administering a cycle of pulsatile FSH to women with obesity and comparing their hormone output to a cycle using conventional daily FSH injection at the identical daily dose The primary outcome will be luteal phase progesterone excretion
Specific Aim To test the hypothesis that pulsatile IV administration of FSH will rescue the impaired folliculogenesis and relative hypogonadotropic hypogonadism characteristic of obesity The investigators will accomplish this by administering a cycle of pulsatile FSH to women with obesity and comparing their hormone output to a cycle using conventional daily FSH injection at the identical daily dose The primary outcome will be luteal phase progesterone excretion
Detailed Description:
Design Crossover interventional study The investigators have selected this design to allow us to compare each woman to herself in consecutive cycles whenever possible
Methods
Patient population and protocol The investigators plan to recruit women with obesity for a proof-of-concept study to demonstrate the potential of this treatment to improve fertility Before such a treatment would be brought into clinical practice a more comprehensive program of pre-conceptional care would be desirable to improve the metabolic health of women with obesity and minimize pregnancy complications such as preterm birth and pregnancy related hypertension
However that is not the goal of this preliminary study which only seeks to identify reproductive hormone impact
ConsentScreening Process A script for screening participants by telephone who inquire in response to advertisements will be used which will include the required verbal consent language Participants who are eligible for enrollment will be asked to come to the Clinical and Translational Research Center CTRC for an intake examination and qualifying laboratory tests At this time informed consent is obtained by the PI the Professional Research Assistant or an Institutional review Board IRB approved designee according to the scripted process The informed consent discussion is always held in a private room that is free of distractions and participants are allowed the opportunity to ask questions and have their questions answered to their satisfaction before signing the informed consent document Once informed consent has been provided procedures are performed as outlined in the procedures section
The investigators will prepare the participants for either a cycle of pulsatile FSH or conventional daily FSH injection at the identical daily dose of FSH for both conditions Participants will be randomized to group A pulsatile FSH and then conventional daily injected FSH or group B conventional FSH and then pulsatile FSH by the study statistician Participants will not be blinded to treatment However the PI and co-investigator as well as the research assistant who will perform the assays will not be expected to be involved in direct care of participants during treatment and will therefore be able to remain blinded to treatment assignment
To control hormone delivery for both conditions non-pulsatile FSH vs pulsatile FSH all participants will receive a Gonadotropin Releasing Hormone GnRH antagonist during gonadotropin stimulation and up to the day of Human Chorionic Gonadotropin HCG trigger to abolish endogenous gonadotropin production A baseline ultrasound will be performed within 2 days of the onset of menses to assure that no dominant follicles are present on ovarian ultrasound and E2 is 50 pgml prior to initiating stimulation as per usual clinical practice The remaining protocol will be administered in the second cycle after a 1-month washout period to avoid the possibility of carryover
Methods
Patient population and protocol The investigators plan to recruit women with obesity for a proof-of-concept study to demonstrate the potential of this treatment to improve fertility Before such a treatment would be brought into clinical practice a more comprehensive program of pre-conceptional care would be desirable to improve the metabolic health of women with obesity and minimize pregnancy complications such as preterm birth and pregnancy related hypertension
However that is not the goal of this preliminary study which only seeks to identify reproductive hormone impact
ConsentScreening Process A script for screening participants by telephone who inquire in response to advertisements will be used which will include the required verbal consent language Participants who are eligible for enrollment will be asked to come to the Clinical and Translational Research Center CTRC for an intake examination and qualifying laboratory tests At this time informed consent is obtained by the PI the Professional Research Assistant or an Institutional review Board IRB approved designee according to the scripted process The informed consent discussion is always held in a private room that is free of distractions and participants are allowed the opportunity to ask questions and have their questions answered to their satisfaction before signing the informed consent document Once informed consent has been provided procedures are performed as outlined in the procedures section
The investigators will prepare the participants for either a cycle of pulsatile FSH or conventional daily FSH injection at the identical daily dose of FSH for both conditions Participants will be randomized to group A pulsatile FSH and then conventional daily injected FSH or group B conventional FSH and then pulsatile FSH by the study statistician Participants will not be blinded to treatment However the PI and co-investigator as well as the research assistant who will perform the assays will not be expected to be involved in direct care of participants during treatment and will therefore be able to remain blinded to treatment assignment
To control hormone delivery for both conditions non-pulsatile FSH vs pulsatile FSH all participants will receive a Gonadotropin Releasing Hormone GnRH antagonist during gonadotropin stimulation and up to the day of Human Chorionic Gonadotropin HCG trigger to abolish endogenous gonadotropin production A baseline ultrasound will be performed within 2 days of the onset of menses to assure that no dominant follicles are present on ovarian ultrasound and E2 is 50 pgml prior to initiating stimulation as per usual clinical practice The remaining protocol will be administered in the second cycle after a 1-month washout period to avoid the possibility of carryover
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None