PCOS (Polycystic Ovary Syndrome)(SPARK-Pilot)NCT07227363
Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
A study testing Ketogenic diet and Exogenous Ketone Supplement in people with PCOS (Polycystic Ovary Syndrome), run by Ohio State University at 1 site in United States.
Trial summary
The SPARK- Pilot study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week clinical trial at The Ohio State University designed to explore how different ways of achieving ketosis may improve reproductive and metabolic health in women with Polycystic Ovary Syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- Ketogenic diet and Exogenous Ketone Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 18-40 years.
- Clinical diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria (presence of at least two of the following: oligo- or anovulation, clinical or biochemical signs of hyperandrogenism, and/or polycystic ovaries on ultrasound).
- Willingness and ability to comply with all study procedures, including fasting (>10 hours; water only), avoidance of alcohol (>24 hours), and abstaining from exercise (>24 hours) prior to each test visit.
- Willing to maintain current diet, exercise, medication, and supplement habits throughout the study.
- Body mass index (BMI) ≥18 kg/m².
- Access to a smartphone, computer, or tablet for digital tracking and study communication.
Who cannot join
- Current adherence to a low-carbohydrate diet (<30% of total energy from carbohydrates).
- Non-PCOS etiologies of anovulation (e.g., menopause, oophorectomy, or other reproductive disorders).
- History of type 1 diabetes or uncontrolled type 2 diabetes.
- Weight loss ≥10% of body weight within the previous 6 months.
- Pregnancy or breastfeeding.
- Use of hormonal contraception or medications known to alter reproductive hormones within 3 months prior to enrollment.
- Active eating disorder or medical condition that could interfere with dietary intervention.
- Any condition that, in the opinion of the Investigator, could interfere with participation, data integrity, or safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210-1442
Madison Kackley, 6142479650, Kackley.19@osu.edu
About this study
The SPARK- Pilot study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week clinical trial at The Ohio State University designed to explore how different ways of achieving ketosis may improve reproductive and metabolic health in women with Polycystic Ovary Syndrome (PCOS).
Participants will be randomly assigned to one of two groups:
Read more
- A ketogenic diet group, following a low-carbohydrate, nutrient-dense meal plan.
- A mixed diet plus ketone supplement group, following general dietary guidelines while taking an exogenous ketone supplement.
The study will measure whether these approaches help restore regular ovulation and improve hormone balance, metabolism, and overall well-being. Optional imaging using MRI will also examine heart and ovarian health.
This pilot study will help researchers understand if ketogenic nutrition strategies are a safe, effective way to support menstrual regularity and reduce PCOS-related symptoms, providing groundwork for larger clinical trials.
Read the detailed description
The SPARK study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week randomized, two-arm intervention examining how nutritional ketosis influences ovulatory and metabolic outcomes in women with Polycystic Ovary Syndrome (PCOS).
PCOS is a common endocrine disorder that affects hormone balance, menstrual function, and metabolism. Current treatments often address single symptoms but rarely provide comprehensive improvement. Ketogenic dietary interventions have shown promise for improving insulin sensitivity, hormone profiles, and body composition; however, few studies have evaluated their direct impact on ovulation.
In this pilot trial, 40 women aged 18-40 years with diagnosed PCOS will be randomized to one of two groups:
Ketogenic Diet (KD): Participants will follow a low-carbohydrate, high-fat, moderate-protein diet designed to achieve and maintain nutritional ketosis (β-hydroxybutyrate ≥0.5 mmol/L).
Mixed Diet + Exogenous Ketone Supplement: Participants will consume a balanced diet aligned with USDA macronutrient recommendations and receive a ketone ester supplement.
Primary outcomes include changes in ovulatory status, assessed through hormonal markers, ovulation prediction tests, and continuous basal body temperature monitoring (OvuSense). Secondary outcomes include changes in reproductive hormones (progesterone, estrogen, LH, FSH), metabolic and lipid markers, and exploratory imaging of cardiovascular function and ovarian morphology via MRI.
This study will provide feasibility and preliminary efficacy data to inform a future large-scale clinical trial evaluating ketogenic strategies for improving menstrual regularity and overall health in women with PCOS.
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- Ketogenic diet, Exogenous Ketone Supplement
- Keywords
- Ketogenic Diet, Exogenous Ketones, Nutritional Ketosis, Reproductive Hormones, Ovarian Function, Women's Health, Metabolic Health, PCOS
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietOther
A well-formulated ketogenic diet designed to achieve nutritional ketosis (β-hydroxybutyrate ≥0.5 mmol/L). The diet emphasizes non-starchy vegetables as the primary carbohydrate source (20-50 g/day), moderate protein intake (1.2-1.6 g/kg/day), and sufficient dietary fat for energy and satiety. All meals and snacks will be provided during the initial two weeks, followed by a self-guided phase with ongoing dietitian support and education materials. Participants will monitor daily fasting ketones and glucose using a handheld analyzer (KetoMojo).
Exogenous Ketone SupplementDietary supplement
A dietary supplement containing a ketone ester designed to elevate circulating β-hydroxybutyrate concentrations to nutritional ketosis levels without carbohydrate restriction. Participants will consume the supplement throughout the 12-week intervention while following a balanced, mixed diet consistent with USDA dietary guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet (KD) | Experimental | Participants in this arm will follow a well-formulated ketogenic diet designed to achieve and maintain nutritional ketosis (β-hydroxybutyrate ≥0.5 mmol/L). The diet will include non-starchy vegetables as the primary carbohydrate source (20-50 g/day), moderate protein (1.2-1.6 g/kg/day), and sufficient fat for energy and satiety. All meals and snacks will be provided for the first 2 weeks, followed by self-guided adherence with support from the study dietitian and educational resources. Daily fingerstick ketone and glucose levels will be monitored using KetoMojo. Receives: Other: Ketogenic diet |
| Mixed Diet + Exogenous Ketone Supplement | Active comparator | Participants in this arm will follow a balanced, mixed diet aligned with USDA macronutrient recommendations while consuming an exogenous ketone supplement throughout the 12-week intervention. The supplement is designed to raise circulating β-hydroxybutyrate to nutritional ketosis levels without carbohydrate restriction. As with the KD arm, all meals and snacks will be provided for the first 2 weeks, followed by self-guided adherence with ongoing dietitian support. Receives: Dietary Supplement: Exogenous Ketone Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ovulatory Status
To evaluate whether ketogenic dietary intervention or exogenous ketone supplementation restores ovulatory function in women with Polycystic Ovary Syndrome (PCOS). Ovulatory status will be assessed using a combination of validated measures, including basal body temperature monitoring via BBT, urinary luteinizing hormone (LH) surge detection using ovulation predictor kits, and serum progesterone levels. Participants will be classified as ovulatory or anovulatory based on hormonal and temperature cycle confirmation.
Measured: Baseline to 12 weeks
Secondary outcomes (11)
Change in Serum Progesterone Concentration (ng/mL)
To determine the effects of ketogenic diet and exogenous ketone supplementation on circulating reproductive hormone concentrations. Serum progesterone will be analyzed using standard immunoassay techniques (Quest Diagnostics panels and/or validated ELISA assays). Hormonal changes will be compared between baseline and post-intervention to assess improvements in reproductive axis regulation.
Measured: Baseline to 12 weeks
Change in Serum Estradiol Concentration (pg/mL)
To determine the effects of ketogenic diet and exogenous ketone supplementation on circulating reproductive hormone concentrations. Serum estradiol will be analyzed using commercially available immunoassay kits (Quest Diagnostics panels and/or validated ELISA assays). Hormonal changes will be compared between baseline and post-intervention to assess improvements in reproductive axis regulation.
Measured: Baseline to 12 weeks
Change in Serum Luteinizing Hormone Concentration (mIU/mL)
To determine the effects of ketogenic diet and exogenous ketone supplementation on circulating reproductive hormone concentrations. Serum luteinizing hormone (LH) will be analyzed using standard immunoassay techniques (Quest Diagnostics panels and/or validated ELISA assays). Hormonal changes will be compared between baseline and post-intervention to assess improvements in reproductive axis regulation.
Measured: Baseline to 12 weeks
Change in Serum Follicle Stimulating Hormone Concentrations (mIU/mL)
To determine the effects of ketogenic diet and exogenous ketone supplementation on circulating reproductive hormone concentrations. Serum follicle-stimulating hormone (FSH) will be analyzed using standard immunoassay techniques (Quest Diagnostics panels and/or validated ELISA assays). Hormonal changes will be compared between baseline and post-intervention to assess improvements in reproductive axis regulation.
Measured: Baseline to 12 weeks
Change in Daily Fasting BHB (mmol/L)
To assess changes in metabolic parameters including fasting β-hydroxybutyrate (BHB). Capillary ketones will be measured daily using KetoMojo handheld monitors.
Measured: Baseline to 12 weeks (Daily)
Change in Daily Fasting Glucose (mg/dL)
To assess changes in metabolic parameters including fasting glucose. Capillary glucose will be measured daily using KetoMojo handheld monitors.
Measured: Baseline to 12 weeks (Daily)
Change in Serum Insulin Concentration (µIU/mL)
To assess the effect of ketogenic diet and exogenous ketone supplementation on fasting insulin levels. Serum insulin will be measured at laboratory visits via immunoassay (Quest Diagnostics or validated ELISA). Mean change from baseline will be compared across groups.
Measured: Baseline to 12 weeks
Change in Serum Total Cholesterol Concentration (mg/dL)
To assess changes in fasting serum total cholesterol in response to ketogenic diet and exogenous ketone supplementation. Blood samples will be collected biweekly and analyzed using standard clinical chemistry methods (Quest Diagnostics). Mean change from baseline to 12 weeks will be reported.
Measured: Baseline to 12 weeks
Change in Serum Triglyceride Concentration (mg/dL)
To determine the effect of ketogenic diet and exogenous ketone supplementation on fasting triglyceride concentrations. Serum triglycerides will be measured via standard lipid panel. Mean change from baseline to 12 weeks will be compared across groups.
Measured: Baseline to 12 weeks
Change in Serum LDL Cholesterol Concentration (mg/dL)
To assess the effect of ketogenic diet and exogenous ketone supplementation on fasting low-density lipoprotein (LDL) cholesterol. Serum LDL will be measured via standard lipid panel (Quest Diagnostics). Mean change from baseline to post-intervention will be reported.
Measured: Baseline to 12 weeks
Change in Serum HDL Cholesterol Concentration (mg/dL)
To evaluate changes in fasting high-density lipoprotein (HDL) cholesterol following ketogenic diet or exogenous ketone supplementation. Serum HDL will be analyzed by clinical chemistry methods. Mean change from baseline to 12 weeks will be reported.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start1 Dec 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madison Kackley, Ohio State University
- Investigators
- Madison Kackley, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227363
- Sponsor's protocol ID
- 2023H0368
- Acronym
- (SPARK-Pilot)
- Status last verified
- May 2026
- First submitted
- 6 Nov 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is an early-stage pilot study focused on feasibility and exploratory outcomes. At this stage, individual participant data (IPD) will not be publicly shared until all analyses are complete and findings are published. De-identified aggregate data may be shared upon reasonable request following publication, in accordance with institutional and IRB policies. If a larger, follow-up trial is initiated, a formal data-sharing plan will be developed to align with NIH and ICMJE requirements.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
- ClinicalTrials.gov ID
- NCT07227363
- Acronym / sponsor ID
- (SPARK-Pilot) / 2023H0368
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Keywords
- Ketogenic Diet, Exogenous Ketones, Nutritional Ketosis, Reproductive Hormones, Ovarian Function, Women's Health, Metabolic Health, PCOS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Nov 2025 (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 SPARK- Pilot study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week clinical trial at The Ohio State University designed to explore how different ways of achieving ketosis may improve reproductive and metabolic health in women with Polycystic Ovary Syndrome (PCOS).
Participants will be randomly assigned to one of two groups:
- A ketogenic diet group, following a low-carbohydrate, nutrient-dense meal plan.
- A mixed diet plus ketone supplement group, following general dietary guidelines while taking an exogenous ketone supplement.
The study will measure whether these approaches help restore regular ovulation and improve hormone balance, metabolism, and overall well-being. Optional imaging using MRI will also examine heart and ovarian health.
This pilot study will help researchers understand if ketogenic nutrition strategies are a safe, effective way to support menstrual regularity and reduce PCOS-related symptoms, providing groundwork for larger clinical trials.
Detailed description
The SPARK study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week randomized, two-arm intervention examining how nutritional ketosis influences ovulatory and metabolic outcomes in women with Polycystic Ovary Syndrome (PCOS).
PCOS is a common endocrine disorder that affects hormone balance, menstrual function, and metabolism. Current treatments often address single symptoms but rarely provide comprehensive improvement. Ketogenic dietary interventions have shown promise for improving insulin sensitivity, hormone profiles, and body composition; however, few studies have evaluated their direct impact on ovulation.
In this pilot trial, 40 women aged 18-40 years with diagnosed PCOS will be randomized to one of two groups:
Ketogenic Diet (KD): Participants will follow a low-carbohydrate, high-fat, moderate-protein diet designed to achieve and maintain nutritional ketosis (β-hydroxybutyrate ≥0.5 mmol/L).
Mixed Diet + Exogenous Ketone Supplement: Participants will consume a balanced diet aligned with USDA macronutrient recommendations and receive a ketone ester supplement.
Primary outcomes include changes in ovulatory status, assessed through hormonal markers, ovulation prediction tests, and continuous basal body temperature monitoring (OvuSense). Secondary outcomes include changes in reproductive hormones (progesterone, estrogen, LH, FSH), metabolic and lipid markers, and exploratory imaging of cardiovascular function and ovarian morphology via MRI.
This study will provide feasibility and preliminary efficacy data to inform a future large-scale clinical trial evaluating ketogenic strategies for improving menstrual regularity and overall health in women with PCOS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet (KD) | Experimental | Other: Ketogenic dietParticipants in this arm will follow a well-formulated ketogenic diet designed to achieve and maintain nutritional ketosis (β-hydroxybutyrate ≥0.5 mmol/L). The diet will include non-starchy vegetables as the primary carbohydrate source (20-50 g/day), moderate protein (1.2-1.6 g/kg/day), and sufficient fat for energy and satiety. All meals and snacks will be provided for the first 2 weeks, followed by self-guided adherence with support from the study dietitian and educational resources. Daily fingerstick ketone and glucose levels will be monitored using KetoMojo. |
| Mixed Diet + Exogenous Ketone Supplement | Active comparator | Dietary Supplement: Exogenous Ketone SupplementParticipants in this arm will follow a balanced, mixed diet aligned with USDA macronutrient recommendations while consuming an exogenous ketone supplement throughout the 12-week intervention. The supplement is designed to raise circulating β-hydroxybutyrate to nutritional ketosis levels without carbohydrate restriction. As with the KD arm, all meals and snacks will be provided for the first 2 weeks, followed by self-guided adherence with ongoing dietitian support. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female participants aged 18-40 years.
- Clinical diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria (presence of at least two of the following: oligo- or anovulation, clinical or biochemical signs of hyperandrogenism, and/or polycystic ovaries on ultrasound).
- Willingness and ability to comply with all study procedures, including fasting (>10 hours; water only), avoidance of alcohol (>24 hours), and abstaining from exercise (>24 hours) prior to each test visit.
- Willing to maintain current diet, exercise, medication, and supplement habits throughout the study.
- Body mass index (BMI) ≥18 kg/m².
Key exclusion criteria (8 listed)
- Current adherence to a low-carbohydrate diet (<30% of total energy from carbohydrates).
- Non-PCOS etiologies of anovulation (e.g., menopause, oophorectomy, or other reproductive disorders).
- History of type 1 diabetes or uncontrolled type 2 diabetes.
- Weight loss ≥10% of body weight within the previous 6 months.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Ketogenic dietA well-formulated ketogenic diet designed to achieve nutritional ketosis (β-hydroxybutyrate ≥0.5 mmol/L). The diet emphasizes non-starchy vegetables as the primary carbohydrate source (20-50 g/day), moderate protein intake (1.2-1.6 g/kg/day), and sufficient dietary fat for energy and satiety. All meals and snacks will be provided during the initial two weeks, followed by a self-guided phase with ongoing dietitian support and education materials. Participants will monitor daily fasting ketones and glucose using a handheld analyzer (KetoMojo). | Other | Ketogenic Diet (KD) |
| Exogenous Ketone SupplementA dietary supplement containing a ketone ester designed to elevate circulating β-hydroxybutyrate concentrations to nutritional ketosis levels without carbohydrate restriction. Participants will consume the supplement throughout the 12-week intervention while following a balanced, mixed diet consistent with USDA dietary guidelines. | Dietary supplement | Mixed Diet + Exogenous Ketone Supplement |
Primary outcome
Change in Ovulatory Status
Time frame: Baseline to 12 weeks
To evaluate whether ketogenic dietary intervention or exogenous ketone supplementation restores ovulatory function in women with Polycystic Ovary Syndrome (PCOS). Ovulatory status will be assessed using a combination of validated measures, including basal body temperature monitoring via BBT, urinary luteinizing hormone (LH) surge detection using ovulation predictor kits, and serum progesterone levels. Participants will be classified as ovulatory or anovulatory based on hormonal and temperature cycle confirmation.
11 secondary outcomes
Change in Serum Progesterone Concentration (ng/mL)
Time frame: Baseline to 12 weeks
Change in Serum Estradiol Concentration (pg/mL)
Time frame: Baseline to 12 weeks
Change in Serum Luteinizing Hormone Concentration (mIU/mL)
Time frame: Baseline to 12 weeks
Change in Serum Follicle Stimulating Hormone Concentrations (mIU/mL)
Time frame: Baseline to 12 weeks
Change in Daily Fasting BHB (mmol/L)
Time frame: Baseline to 12 weeks (Daily)
Change in Daily Fasting Glucose (mg/dL)
Time frame: Baseline to 12 weeks (Daily)
Change in Serum Insulin Concentration (µIU/mL)
Time frame: Baseline to 12 weeks
Change in Serum Total Cholesterol Concentration (mg/dL)
Time frame: Baseline to 12 weeks
Change in Serum Triglyceride Concentration (mg/dL)
Time frame: Baseline to 12 weeks
Change in Serum LDL Cholesterol Concentration (mg/dL)
Time frame: Baseline to 12 weeks
Change in Serum HDL Cholesterol Concentration (mg/dL)
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided. This is an early-stage pilot study focused on feasibility and exploratory outcomes. At this stage, individual participant data (IPD) will not be publicly shared until all analyses are complete and findings are published. De-identified aggregate data may be shared upon reasonable request following publication, in accordance with institutional and IRB policies. If a larger, follow-up trial is initiated, a formal data-sharing plan will be developed to align with NIH and ICMJE requirements.
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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.
Madison Kackley, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet and Exogenous Ketone Supplement in people with PCOS (Polycystic Ovary Syndrome), run by Ohio State University 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madison Kackley, PhD (16142479650, Kackley.19@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ovulatory Status (time frame: Baseline to 12 weeks). 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 8 May 2026.