Ignite Creation Date:
2024-05-06 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03604770
Status:
WITHDRAWN
Last Update Posted:
2020-01-09
First Post:
2018-07-19
Brief Title:
Caloric Intake and Ovarian Reserve
Sponsor:
TriHealth Inc
Organization:
TriHealth Inc
Study Overview
Official Title:
Caloric Intake and Ovarian Reserve
Status:
WITHDRAWN
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to observe the impact of caloric intake on ovarian reserve as measured by anti-müllerian hormone AMH levels and antral follicles AFC visualized on ultrasound It has been shown that obesity negatively impacts these markers but research is lacking regarding the influence of nutrition and caloric intake on fertility This would give the investigators information on how diet may impact ovarian reserve in patients seeking fertility treatment
Detailed Description:
Obesity has been linked to poorer quality oocytes fewer embryos and poorer outcomes with pregnancy rates and live birth rates when compared to normal BMI patients Animal and human studies have shown that short term caloric restriction has lead to improved oocyte quality Clearly obesity has a negative effect on egg quality Is this related to the caloric quantity that these patients are consuming when compared with normal BMI patients If caloric quantity has an impact on egg quality and quantity then more accurate nutritional guidance could be provided to obese patients who desire to undergo fertility treatments to achieve pregnancy This could ultimately lead to an improvement in pregnancy rates and live birth rates for these patients
The goal is to create a survey that would ask patients questions about their caloric intake and activity level They would also be provided with a food diary to track their caloric intake over a three-day period They will be instructed to complete the diary during a three day period that would represent their typical diet without any modifications or deviations The investigators would take the information from this survey to look at average daily caloric intake for a single patient This data would then be compared with AMH anti-müllerian hormone levels and antral follicle counts AFC seen on US that would be accessible through the patients chart This data would be readily accessible as it is part of all patients initial workup for infertility assessment and treatment The investigators would allow for up to a 12 month time period between when these lab and ultrasound findings were performed and when the patient is enrolled in the research study in order to accurately reflect patients average caloric intake
Antral follicles are visualized and measured by transvaginal ultrasound and defined as measuring 2-10mm in diameter This study would define a low AFC ranging from 0-10 antral follicles seen between days two and four of a regular menstrual cycle and would be consistent with poor ovarian reserve AMH is a hormone level that is expressed by early follicles and reflects the size of the follicle pool This level represents ovarian function and provides additional information on ovarian reserve This level can be measured anytime during the menstrual cycle Normal and abnormal values for the AMH lab value will be determined in this study by the specific laboratory assay that is used by Trihealth and what that laboratorys reference ranges are since there is not an accepted standardized range
The goal is to create a survey that would ask patients questions about their caloric intake and activity level They would also be provided with a food diary to track their caloric intake over a three-day period They will be instructed to complete the diary during a three day period that would represent their typical diet without any modifications or deviations The investigators would take the information from this survey to look at average daily caloric intake for a single patient This data would then be compared with AMH anti-müllerian hormone levels and antral follicle counts AFC seen on US that would be accessible through the patients chart This data would be readily accessible as it is part of all patients initial workup for infertility assessment and treatment The investigators would allow for up to a 12 month time period between when these lab and ultrasound findings were performed and when the patient is enrolled in the research study in order to accurately reflect patients average caloric intake
Antral follicles are visualized and measured by transvaginal ultrasound and defined as measuring 2-10mm in diameter This study would define a low AFC ranging from 0-10 antral follicles seen between days two and four of a regular menstrual cycle and would be consistent with poor ovarian reserve AMH is a hormone level that is expressed by early follicles and reflects the size of the follicle pool This level represents ovarian function and provides additional information on ovarian reserve This level can be measured anytime during the menstrual cycle Normal and abnormal values for the AMH lab value will be determined in this study by the specific laboratory assay that is used by Trihealth and what that laboratorys reference ranges are since there is not an accepted standardized range
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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