Fertility IssuesPROWESSNCT06297070
Lifestyle Care for Fertility Outcome Evaluation
An observational study of Fertility Issues, run by Christine Kaiser, LAc, DACM at 1 site in United States.
Trial summary
An observational outcome evaluation of the Lifestyle Care for Fertility program. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Fertility Issues
- What is being tested?
- Whole Health Lifestyle Care for Reproductive Well-being pilot program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to 20 Jun 2025
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Study participants will be patients of University Hospitals Connor Whole Health who have a fertility-related diagnosis and who are participating in the Lifestyle Care for Fertility program
Who may be able to join
- Adult with a uterus aged from 18 to 50 years
- Participating in the Lifestyle Care for Fertility program
- Able to speak and understand English.
- Has email address and access to mobile device with a functioning data plan.
- Infertility-related diagnosis
Who cannot join
- Age < 18 or > 50 years
- Having a significant and uncorrected visual, hearing, or cognitive impairment
- Inability to provide consent
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Promoting ReprOductive WellbEing Through Shared Medical Appointments and Health Coaching Sessions
An observational outcome evaluation of the Lifestyle Care for Fertility program.
Read the detailed description
This outcome evaluation will examine the feasibility and acceptability of the Whole Health Lifestyle Care for Reproductive Well-being Pilot Program ("Lifestyle Care for Fertility" or LCF) and collection of health behavior and patient-reported outcomes. Secondarily, it will also examine the longitudinal changes in health behaviors and patient-reported outcomes of participants in the Lifestyle Care for Fertility program
The Lifestyle Care for Fertility program serves women who have a fertility-related diagnosis. The program consists of an individual Integrative Health and Medicine (IHM) consultation with a CWH IHM provider, 4 Shared Medical Appointments (SMA), and 4 individual Health and Wellness Coaching (HWC) sessions. The SMA sessions occur at the UH CWH Beachwood office conference and movement rooms. The HWC sessions are virtual. The consultations are either virtual or in person at UH CWH Beachwood. Topics include meditation, sleep, yoga/exercise/movement, acupuncture, and nutrition
Participation in the program is not contingent on participation in the outcome evaluation. Patients with a uterus aged 18-50 who have a fertility-related diagnosis are eligible to participate in the program. Participants in the outcome evaluation will be a subset of the participants in the program who give their consent to researchers to collect survey and EHR data.
The outcome evaluation will collect data at 4 weeks, 8 weeks, and before, after, and in between each of the 8 weekly sessions. Data collected at baseline include demographics, PROMIS Sleep Disturbance 8a, Perceived Stress Scale 4 (PSS-4), Infertility Self Efficacy Scale (ISE), and current Health Behaviors (HB). The HB survey will be administered between Sessions 1-8, as well as after Session 8, to observe any longitudinal changes. Patients will complete the PROMIS Sleep Disturbance 8a, PSS-4, and ISE at 4 weeks and 8 weeks. Pre- and post-session data includes 0-10 NRS ratings of stress, energy, focus, well-being, perceived support (post-only), and satisfaction (post-only). Additionally, participants will complete a satisfaction survey post Session 8. All data will be collected in REDCap via a text message or email link sent to the participant. Research staff will review the participant's medical record to collect data on the participant's demographics and clinical characteristics at baseline, and to collect chemical pregnancy data at six months after the 8 sessions have been completed. Attendance data about participants will also be collected.
- Conditions
- Fertility Issues
- Being tested
- Whole Health Lifestyle Care for Reproductive Well-being pilot program
- Keywords
- fertility, shared medical appointments, health coaching, quality of life
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Health Lifestyle Care for Reproductive Well-being pilot programBehavioural
Also called Lifestyle Care for Fertility
The program consists of an individual Integrative Health and Medicine (IHM) consultation with a CWH IHM provider, 4 Shared Medical Appointments (SMA), and 4 individual Health and Wellness Coaching (HWC) sessions. The SMA sessions occur at the UH CWH Beachwood office conference and movement rooms. The HWC sessions are virtual. The consultations are either virtual or in person at UH CWH Beachwood.
What is being measured
The primary outcome is the main question the study is designed to answer.
Servings of Fruit
Number of servings of fruit consumed each day. A serving is about 1 medium piece, or 1/2 cup of fruit.
Measured: 8 weeks
Servings of Vegetables
Number of servings of vegetables consumed each day. A serving is about 1 cup of raw leafy vegetables, 1/2 cup of other cooked or raw vegetables, or 3/4 cup of raw vegetable juice.
Measured: 8 weeks
Glasses of Water
Number of glasses (8 oz) of plain water consumed per day.
Measured: 8 weeks
Caffeinated Beverages
Number of caffeinated beverages consumed per day.
Measured: 8 weeks
Aerobic Exercise
Frequency of aerobic exercise (min 20 min) in last week.
Measured: 8 Weeks
Strengthening Exercise
Frequency of muscle strengthening exercise (min 20 min) in last week.
Measured: 8 weeks
Stretching Exercise
Frequency of stretching exercise in last week.
Measured: 8 weeks
Sleep Hygiene
Frequency of sleep hygiene practices before bed in last week.
Measured: 8 weeks
Hours of Sleep
Average number of hours of sleep per night in last week.
Measured: 8 weeks
Self Care - Biofeedback
Frequency of use of biofeedback in last week.
Measured: 8 weeks
Self Care - Breathing Exercises
Frequency of breathing exercise practice in last week.
Measured: 8 weeks
Self Care - Guided Imagery
Frequency of guided imagery practice in last week.
Measured: 8 weeks
Self Care - Mindfulness/Meditation
Frequency of mindfulness/meditation practice in last week.
Measured: 8 weeks
Self Care - Progressive Relaxation
Frequency of progressive relaxation practice in last week.
Measured: 8 weeks
Self Care - Journaling/Gratitude Journaling
Frequency of journaling or gratitude journaling in last week.
Measured: 8 weeks
Self Care - Tai Chi/Chi Gong
Frequency of Tai Chi or Chi Gong practice in last week.
Measured: 8 weeks
Self-Care - Massage Therapy
Frequency of receipt of massage therapy in last week.
Measured: 8 weeks
Self Care - Acupuncture/Acupressure
Frequency of receipt of acupuncture or acupressure in last week.
Measured: 8 weeks
Self Care - Nature Walking
Frequency of walking in nature in last week.
Measured: 8 weeks
Secondary outcomes (37)
PROMIS Sleep Disturbance 8a
Composite score (8 -40 with higher scores representing a better outcome) measuring self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours within the past seven days.
Measured: 8 weeks
Perceived Stress Scale - 4
Composite score (0-16 with higher scores representing a better outcome) measuring self-reported perception of stress.
Measured: 8 weeks
Infertility Self Efficacy
Composite score (16-144 with higher scores representing a better outcome) measuring self-reported perceived self-efficacy for coping with a diagnosis and treatment for infertility.
Measured: 8 weeks
Chemical pregnancy
Pregnancy as confirmed by presence of human chorionic gonadotropin (hCG) within 6 months of program completion.
Measured: 8 months
Stress Change (level of stress: none [0] to worst possible [10]) - SMA
Change in 11 point numerical rating scale. Range from -11 to 11, with lower scores representing better outcomes: Change in stress level from pre to post each of the 4 shared medical appointment sessions.
Measured: 2 hours
Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - SMA
Change in 11 point numerical rating scale. Range from -11 to 11, with lower scores representing better outcomes: Change in anxiety level from pre to post each of the 4 shared medical appointment sessions.
Measured: 2 hours
Energy Change (level of energy right now: no energy [0] to most energized [10]) - SMA
Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in energy level from pre to post each of the 4 shared medical appointment sessions.
Measured: 2 hours
Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - SMA
Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in focus level from pre to post each of the 4 shared medical appointment sessions.
Measured: 2 hours
Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - SMA
Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in wellbeing level from pre to post each of the 4 shared medical appointment sessions.
Measured: 2 hours
Stress Change (level of stress: none [0] to worst possible [10]) - HWC
Change in 11 point numerical rating scale. Range from -11 to 11, with lower scores representing better outcomes:
Change in stress level from pre to post each of the 4 health and wellness coaching sessions.
Measured: 45 minutes
Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - HWC
Change in 11 point numerical rating scale. Range from -11 to 11, with lower scores representing better outcomes: Change in anxiety level from pre to post each of the 4 health and wellness coaching sessions.
Measured: 45 minutes
Energy Change (level of energy right now: no energy [0] to most energized [10]) - HWC
Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in energy level from pre to post each of the 4 health and wellness coaching sessions.
Measured: 45 minutes
Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - HWC
Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in focus level from pre to post each of the 4 health and wellness coaching sessions.
Measured: 45 minutes
Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - HWC
Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in wellbeing level from pre to post each of the 4 health and wellness coaching sessions.
Measured: 45 minutes
Recruitment Rate
Number enrolled over number approached.
Measured: 4-6 weeks
Retention Rate
Percent of participants retained at each data collection point
Measured: 8 weeks
Pace of Accrual
Number of participants enrolled from each program cohort.
Measured: 8 weeks
Data Completeness
Percent of data collection that is completed
Measured: 8 weeks
Helpfulness of group sessions in addressing needs
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Measured: 8 weeks
Coverage of important issues in the sessions
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Measured: 8 weeks
Helpfulness of tools presented in nutrition session
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Measured: 8 weeks
Helpfulness of tools presented in movement session
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Measured: 8 weeks
Helpfulness of tools presented in relaxation and sleep session
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Measured: 8 weeks
Helpfulness of tools presented in integrate session
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Measured: 8 weeks
Enjoyed group sessions
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Measured: 8 weeks
Enjoyed health and wellness coaching session
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Measured: 8 weeks
Group setting was beneficial
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Measured: 8 weeks
Comfortable in group setting
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Measured: 8 weeks
Helpfulness of individual health coaching sessions
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Measured: 8 weeks
Feedback questionnaire: Location Preference question 1
Shared Medical Appointment session location preference. Choices: virtual, in person or no preference.
Measured: 8 weeks
Feedback questionnaire: Location Preference question 2
Health and Wellness Coaching session location preference. Choices: virtual, in person or no preference.
Measured: 8 weeks
Feedback questionnaire: Number of Sessions question.
Opinion on number of sessions. Choices: too few, just right, too many.
Measured: 8 weeks
Feedback questionnaire: Length of Sessions question.
Opinion on length of sessions. Choices: too short, just right, too long.
Measured: 8 weeks
Rating of level of support during each SMA
11-point Likert scale not supported to very well supported (0 - 10 with higher scores representing better outcomes): Level of support received during each of the 4 shared medical appointment sessions.
Measured: 2 hours
Rating of level of support during HWC
11-point Likert scale not supported to very well supported (0 - 10 with higher scores representing better outcomes): Level of support received during each of the 4 health and wellness coaching sessions.
Measured: 45 minutes
Overall level of satisfaction during each SMA
11-point Likert scale not at all satisfied to very well satisfied (0 - 10 with higher scores representing better outcomes): Overall level of satisfaction with each of the 4 shared medical appointment sessions.
Measured: 2 hours
Overall level of satisfaction during each HWC
11-point Likert scale not at all satisfied to very well satisfied (0 - 10 with higher scores representing better outcomes): Overall level of satisfaction with each of the 4 health and wellness coaching sessions.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start24 Jan 2024
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christine Kaiser, LAc, DACM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christine Kaiser, LAc, DACM, University Hospitals Cleveland Medical Center
- Investigators
- Christine Kaiser, DACM LAc, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297070
- Sponsor's protocol ID
- STUDY20231406
- Acronym
- PROWESS
- Status last verified
- Jul 2025
- First submitted
- 28 Feb 2024
- Last updated
- 18 Jul 2025
- 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 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting ReprOductive WellbEing Through Shared Medical Appointments and Health Coaching Sessions
- ClinicalTrials.gov ID
- NCT06297070
- Acronym / sponsor ID
- PROWESS / STUDY20231406
- Conditions
- Fertility Issues
- Keywords
- fertility, shared medical appointments, health coaching, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Christine Kaiser, LAc, DACMUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 6 Mar 2024 (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.
An observational outcome evaluation of the Lifestyle Care for Fertility program.
Detailed description
This outcome evaluation will examine the feasibility and acceptability of the Whole Health Lifestyle Care for Reproductive Well-being Pilot Program ("Lifestyle Care for Fertility" or LCF) and collection of health behavior and patient-reported outcomes. Secondarily, it will also examine the longitudinal changes in health behaviors and patient-reported outcomes of participants in the Lifestyle Care for Fertility program
The Lifestyle Care for Fertility program serves women who have a fertility-related diagnosis. The program consists of an individual Integrative Health and Medicine (IHM) consultation with a CWH IHM provider, 4 Shared Medical Appointments (SMA), and 4 individual Health and Wellness Coaching (HWC) sessions. The SMA sessions occur at the UH CWH Beachwood office conference and movement rooms. The HWC sessions are virtual. The consultations are either virtual or in person at UH CWH Beachwood. Topics include meditation, sleep, yoga/exercise/movement, acupuncture, and nutrition
Participation in the program is not contingent on participation in the outcome evaluation. Patients with a uterus aged 18-50 who have a fertility-related diagnosis are eligible to participate in the program. Participants in the outcome evaluation will be a subset of the participants in the program who give their consent to researchers to collect survey and EHR data.
The outcome evaluation will collect data at 4 weeks, 8 weeks, and before, after, and in between each of the 8 weekly sessions. Data collected at baseline include demographics, PROMIS Sleep Disturbance 8a, Perceived Stress Scale 4 (PSS-4), Infertility Self Efficacy Scale (ISE), and current Health Behaviors (HB). The HB survey will be administered between Sessions 1-8, as well as after Session 8, to observe any longitudinal changes. Patients will complete the PROMIS Sleep Disturbance 8a, PSS-4, and ISE at 4 weeks and 8 weeks. Pre- and post-session data includes 0-10 NRS ratings of stress, energy, focus, well-being, perceived support (post-only), and satisfaction (post-only). Additionally, participants will complete a satisfaction survey post Session 8. All data will be collected in REDCap via a text message or email link sent to the participant. Research staff will review the participant's medical record to collect data on the participant's demographics and clinical characteristics at baseline, and to collect chemical pregnancy data at six months after the 8 sessions have been completed. Attendance data about participants will also be collected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study participants will be patients of University Hospitals Connor Whole Health who have a fertility-related diagnosis and who are participating in the Lifestyle Care for Fertility program
Key inclusion criteria (5 listed)
- Adult with a uterus aged from 18 to 50 years
- Participating in the Lifestyle Care for Fertility program
- Able to speak and understand English.
- Has email address and access to mobile device with a functioning data plan.
- Infertility-related diagnosis
Key exclusion criteria (4 listed)
- Age < 18 or > 50 years
- Having a significant and uncorrected visual, hearing, or cognitive impairment
- Inability to provide consent
- Current pregnancy
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 |
|---|---|---|
| Whole Health Lifestyle Care for Reproductive Well-being pilot programAlso: Lifestyle Care for FertilityThe program consists of an individual Integrative Health and Medicine (IHM) consultation with a CWH IHM provider, 4 Shared Medical Appointments (SMA), and 4 individual Health and Wellness Coaching (HWC) sessions. The SMA sessions occur at the UH CWH Beachwood office conference and movement rooms. The HWC sessions are virtual. The consultations are either virtual or in person at UH CWH Beachwood. | Behavioural | – |
Primary outcome
Servings of Fruit
Time frame: 8 weeks
Number of servings of fruit consumed each day. A serving is about 1 medium piece, or 1/2 cup of fruit.
Servings of Vegetables
Time frame: 8 weeks
Number of servings of vegetables consumed each day. A serving is about 1 cup of raw leafy vegetables, 1/2 cup of other cooked or raw vegetables, or 3/4 cup of raw vegetable juice.
Glasses of Water
Time frame: 8 weeks
Number of glasses (8 oz) of plain water consumed per day.
Caffeinated Beverages
Time frame: 8 weeks
Number of caffeinated beverages consumed per day.
Aerobic Exercise
Time frame: 8 Weeks
Frequency of aerobic exercise (min 20 min) in last week.
Strengthening Exercise
Time frame: 8 weeks
Frequency of muscle strengthening exercise (min 20 min) in last week.
Stretching Exercise
Time frame: 8 weeks
Frequency of stretching exercise in last week.
Sleep Hygiene
Time frame: 8 weeks
Frequency of sleep hygiene practices before bed in last week.
Hours of Sleep
Time frame: 8 weeks
Average number of hours of sleep per night in last week.
Self Care - Biofeedback
Time frame: 8 weeks
Frequency of use of biofeedback in last week.
Self Care - Breathing Exercises
Time frame: 8 weeks
Frequency of breathing exercise practice in last week.
Self Care - Guided Imagery
Time frame: 8 weeks
Frequency of guided imagery practice in last week.
Self Care - Mindfulness/Meditation
Time frame: 8 weeks
Frequency of mindfulness/meditation practice in last week.
Self Care - Progressive Relaxation
Time frame: 8 weeks
Frequency of progressive relaxation practice in last week.
Self Care - Journaling/Gratitude Journaling
Time frame: 8 weeks
Frequency of journaling or gratitude journaling in last week.
Self Care - Tai Chi/Chi Gong
Time frame: 8 weeks
Frequency of Tai Chi or Chi Gong practice in last week.
Self-Care - Massage Therapy
Time frame: 8 weeks
Frequency of receipt of massage therapy in last week.
Self Care - Acupuncture/Acupressure
Time frame: 8 weeks
Frequency of receipt of acupuncture or acupressure in last week.
Self Care - Nature Walking
Time frame: 8 weeks
Frequency of walking in nature in last week.
37 secondary outcomes
PROMIS Sleep Disturbance 8a
Time frame: 8 weeks
Perceived Stress Scale - 4
Time frame: 8 weeks
Infertility Self Efficacy
Time frame: 8 weeks
Chemical pregnancy
Time frame: 8 months
Stress Change (level of stress: none [0] to worst possible [10]) - SMA
Time frame: 2 hours
Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - SMA
Time frame: 2 hours
Energy Change (level of energy right now: no energy [0] to most energized [10]) - SMA
Time frame: 2 hours
Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - SMA
Time frame: 2 hours
Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - SMA
Time frame: 2 hours
Stress Change (level of stress: none [0] to worst possible [10]) - HWC
Time frame: 45 minutes
Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - HWC
Time frame: 45 minutes
Energy Change (level of energy right now: no energy [0] to most energized [10]) - HWC
Time frame: 45 minutes
Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - HWC
Time frame: 45 minutes
Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - HWC
Time frame: 45 minutes
Recruitment Rate
Time frame: 4-6 weeks
Retention Rate
Time frame: 8 weeks
Pace of Accrual
Time frame: 8 weeks
Data Completeness
Time frame: 8 weeks
Helpfulness of group sessions in addressing needs
Time frame: 8 weeks
Coverage of important issues in the sessions
Time frame: 8 weeks
Helpfulness of tools presented in nutrition session
Time frame: 8 weeks
Helpfulness of tools presented in movement session
Time frame: 8 weeks
Helpfulness of tools presented in relaxation and sleep session
Time frame: 8 weeks
Helpfulness of tools presented in integrate session
Time frame: 8 weeks
Enjoyed group sessions
Time frame: 8 weeks
Enjoyed health and wellness coaching session
Time frame: 8 weeks
Group setting was beneficial
Time frame: 8 weeks
Comfortable in group setting
Time frame: 8 weeks
Helpfulness of individual health coaching sessions
Time frame: 8 weeks
Feedback questionnaire: Location Preference question 1
Time frame: 8 weeks
Feedback questionnaire: Location Preference question 2
Time frame: 8 weeks
Feedback questionnaire: Number of Sessions question.
Time frame: 8 weeks
Feedback questionnaire: Length of Sessions question.
Time frame: 8 weeks
Rating of level of support during each SMA
Time frame: 2 hours
Rating of level of support during HWC
Time frame: 45 minutes
Overall level of satisfaction during each SMA
Time frame: 2 hours
Overall level of satisfaction during each HWC
Time frame: 45 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- 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.
Christine Kaiser, DACM LAc principal investigator
University Hospitals Cleveland Medical Center
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 Fertility Issues, run by Christine Kaiser, LAc, DACM 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 18 Jul 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Servings of Fruit (time frame: 8 weeks). The study lists 19 primary outcomes in all. 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 18 Jul 2025.