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WithdrawnNCT03604770Updated Jan 9, 2020

Caloric Intake and Ovarian Reserve

An observational study in Infertility, Female, sponsored by TriHealth Inc.. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-01-09.

Sponsored by TriHealth Inc. · Observational

Why this study was withdrawn
Due to lack of enrollment.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Infertility, Female

Keywords

  • Caloric Intake
  • Anti-mullerian hormone (AMH)
  • Antral follicles (AFC)
  • Infertility
  • Fertility
  • Diet
  • Ovarian Reserve
  • Obesity
  • Nutrition
03

In context

Infertility, Female

553 studies on the registry are indexed under Infertility, Female; 136 are open to participants now.

Browse Infertility, Female studies →

Lead sponsor

TriHealth Inc. is the lead sponsor of 102 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherSurvey & 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.

06

What researchers measure

Primary outcomes

  1. Average Daily Caloric Intake

    Patients will complete a food diary that they will complete over a 3 day period to assess their average caloric intake.

    Time frame: 3 days

07

Study locations

1 site
  • Bethesda Fertility Center
    Cincinnati, Ohio 45220, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03604770
Lead sponsor
TriHealth Inc.
Responsible party
Sponsor
First posted
Jul 27, 2018
Start date
Jan 14, 2019
Primary completion
May 2020 (estimated)
Completion
May 2020 (estimated)
Last update
Jan 9, 2020

Study contacts

Kasey Reynolds, MD
principal investigator · TriHealth Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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