Infertility, FemaleNCT03604770
Caloric Intake and Ovarian Reserve
An observational study of Infertility, Female, run by TriHealth Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Survey & Food Diary
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: Women aged 18-45 who are seeking fertility treatment at the Bethesda Fertility Center
Who may be able to join
- Women aged 18-45 who are seeking fertility treatment at Bethesda Fertility Center will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Infertility, Female
- Being tested
- Survey & Food Diary
- Keywords
- Caloric Intake, Anti-mullerian hormone (AMH), Antral follicles (AFC), Infertility, Fertility, Diet, Ovarian Reserve, Obesity, Nutrition
- Medical subject headings
- Infertility, Female, Infertility, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey & Food DiaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Survey & Food Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start14 Jan 2019
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Why it stopped: Due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kasey Reynolds, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604770
- Sponsor's protocol ID
- 17028
- Status last verified
- Jan 2020
- First submitted
- 19 Jul 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caloric Intake and Ovarian Reserve
- ClinicalTrials.gov ID
- NCT03604770
- Acronym / sponsor ID
- 17028
- Conditions
- Infertility, Female
- Keywords
- Caloric Intake, Anti-mullerian hormone (AMH), Antral follicles (AFC), Infertility, Fertility, Diet, Ovarian Reserve, Obesity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to lack of enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women seeking fertility treatment | – | Other: Survey & Food DiaryWomen aged 18-45 who are seeking fertility treatment at Bethesda Fertility Center will be provided a survey and food diary to complete. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women aged 18-45 who are seeking fertility treatment at the Bethesda Fertility Center
Key inclusion criteria (1 listed)
- Women aged 18-45 who are seeking fertility treatment at Bethesda Fertility Center will be included.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey & Food DiaryPatients 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. | Other | Women seeking fertility treatment |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kasey Reynolds, MD principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daily Caloric Intake (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.