Caloric Intake and Ovarian Reserve

January 6, 2020 updated by: TriHealth Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 patient's 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 laboratory's reference ranges are since there is not an accepted standardized range.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Bethesda Fertility Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women aged 18-45 who are seeking fertility treatment at the Bethesda Fertility Center

Description

Inclusion Criteria:

  • Women aged 18-45 who are seeking fertility treatment at Bethesda Fertility Center will be included.

Exclusion Criteria:

  • Women who have a diagnosis of PCOS will be excluded from the study due to their abnormal AMH and follicle numbers.
  • Women will be excluded if more than 12 months has passed since AMH and AFC levels have been measured.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Women seeking fertility treatment
Women aged 18-45 who are seeking fertility treatment at Bethesda Fertility Center will be provided a survey and food diary to complete.
Other: Survey & Food Diary
Patients will be provided with a 8 question patient survey to complete and return, as well as a food diary that they will complete over a 3 day period to assess their average caloric intake.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average Daily Caloric Intake
Time Frame: 3 days
Patients will complete a food diary that they will complete over a 3 day period to assess their average caloric intake.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TriHealth Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kasey Reynolds, MD, TriHealth Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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