Caloric Intake and Ovarian Reserve

NCT03604770 | Withdrawn

• 1 other identifier: 17028
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Keywords

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

Outcome Measures

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.

  3 days

Study Arms (1)

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

Survey & Food Diary OTHER

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.

Women seeking fertility treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Bethesda Fertility Center

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Infertility, Female; Infertility; Obesity

Interventions

Surveys and Questionnaires; Diet Records

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Records; Organization and Administration; Health Services Administration

Study Officials

• Kasey Reynolds, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: January 14, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)