Sub Fertility, FemaleKiWuANCT04942457
Feasibility and Safety of Fasting in Fertility Treatment
A study testing Fasting in people with Sub Fertility, Female and Fertility Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This exploratory study investigates fasting as a potential supportive therapy in infertility treatment for women suffering from infertility Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Sub Fertility, Female, Fertility Disorders, Cycle Disorders Menstrual
- What is being tested?
- Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jan 2022to 20 Dec 2023
- Phase
- Interventional
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 25 to 45 years
- Unfulfilled desire to have children >1 year
- declaration of consent
- 20 kg/m² ≤ BMI ≤ 40 kg/m²
Who cannot join
- Language barriers
- Previously known serious mental illness or cognitive impairment
- Patients with anatomical/organic damage and proven uterine abnormalities
- Eating disorders in the medical history
- Serious previous internal diseases
- Lack of internet access
- No consent to randomisation
- Participation in other studies
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin
Berlin, 14109
About this study
Official title: Effects of Fasting in Fertility Treatment in Women
This exploratory study investigates fasting as a potential supportive therapy in infertility treatment for women suffering from infertility
Read the detailed description
This 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a novel supportive treatment in infertility. The participants will be randomized in two groups: fasting and waiting list. All groups will be trained and accompanied by medical experts and dieticians. In addition, qualitative interviews will be conducted including individual and focus group interviews with a subgroup of participants.
- Conditions
- Sub Fertility, Female, Fertility Disorders, Cycle Disorders Menstrual, Ovulation Disorder, Ovulation Absent, Ovulation Delayed
- Being tested
- Fasting
- Keywords
- fasting, natural therapies, caloric restriction, lifestyle modification, dietary restriction, dietary intervention, prolonged fasting, weight loss, complementary medicine, integrative medicine
- Medical subject headings
- Infertility, Female, Menstruation Disturbances, Anovulation, Infertility, Fasting, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingBehavioural
Prolonged fasting for 7-10 days (caloric intake <500 kcal in liquid form)
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | Participants will be councelled and accompanied to follow a prolonged fasting regime of 7-10 days in an outpatient setting under medical supervision. Additionally qualitative interviews will be conducted by few participants in the experimental arm, as well as their respective Healthcare Providers (Doctors/Medical Staff). Receives: Behavioral: Fasting |
| Control group | No intervention | waiting list, usual diet should be maintained |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative interview analysis of fasting experience
individual and focus group interviews
Measured: in time frame of 24 weeks after fasting intervention
pregancy rate
pregnancy rate of the participants
Measured: at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline
Secondary outcomes (23)
complication rates in pregnancy
complication rates monitored by the gynaecologist, if applicable
Measured: 12 months after baseline
Hormonal status
FSH, LH, Estrogen, Progesteron
Measured: at the beginning and end of each ovulatory cycle, for up to 12 months
HbA1c
serum parameter
Measured: baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months
WHO-5
Quality of life
Measured: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
diet
questionnaire to examine dietary behaviour
Measured: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
mindfulness
MAAS-questionnaire, validated questionnaire to examine mindfulness
Measured: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
anxiety and depression
HADS-questionnaire, validated questionnaire to examine anxiety and depression
Measured: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
current mood
ASTS-questionnaire, validated questionnaire to examine current mood
Measured: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
experienced stress
Cohen-stress scale, validated questionnaire to examine experienced stress
Measured: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
physical fitness
questionnaire to examine physical fitness
Measured: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
quality of relationship
questionnaire to examine the relationship between the two partners desiring to have a child
Measured: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
psychological stress caused by the unfulfilled desire to have children
questionnaire to examine the psychological stress caused by the unfulfilled desire to have children
Measured: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
gratitude
validated questionnaire to examine gratitude
Measured: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
self-efficacy
ASKU, validated questionnaire to examine self-efficacy
Measured: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
abdominal ultrasound after liver wrap
sonography in a subgroup
Measured: before, during and after the fasting intervention
rate of ovulations
ovulation visible in sonography
Measured: at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline
liver function parameters
serum liver enzymes
Measured: at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months
pyruvate in culture medium of oocytes, if applicable (in case of IVF/ICSI)
chemical composition of culture medium (pyruvate)
Measured: after in vitro fertilisation, if applicable during study period of one year
glucose in culture medium of oocytes, if applicable (in case of IVF/ICSI)
chemical composition of culture medium (glucose)
Measured: after in vitro fertilisation, if applicable during study period of one year
lactate in culture medium of oocytes, if applicable (in case of IVF/ICSI)
chemical composition of culture medium (lactate)
Measured: after in vitro fertilisation, if applicable during study period of one year
Continuous Glucose Monitoring
Continuous Glucose Monitoring via CGM-Device in subgroup
Measured: 14 days after baseline
Ketone bodies in breath
Breath acetone, in subgroup
Measured: up to 4 days before, during and up to 7 days after fasting intervention
Cumulative drug dose for ovulation induction
Cumulative dosage of hormonal therapy for each assisted cycle of ovulation induction
Measured: baseline and until end of treatment for ovulation induction (2-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start10 Jan 2022
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sub Fertility, FemaleStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 parallel groups following different nutritional regimes. Additionally Qualitative Interviews with Patients and Doctors/Medical Staff.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942457
- Sponsor's protocol ID
- KiWuA
- Acronym
- KiWuA
- Status last verified
- Dec 2023
- First submitted
- 10 May 2021
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon request.
Publications
Behling JN, May KT, Batschari K, Sochiera-Plegniere K, Blakeslee SB, Stritter W, Jeitler M, Kandil FI, Kunz B, Pruss A, Michalsen A, Koppold DA. Women's experiences of a medically supervised fasting intervention for infertility: a qualitative study. BMC Womens Health. 2026 Oct 9;26(1):511. doi: 10.1186/s12905-026-04978-y.
PubMed 42855686
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fasting in Fertility Treatment in Women
- ClinicalTrials.gov ID
- NCT04942457
- Acronym / sponsor ID
- KiWuA / KiWuA
- Conditions
- Sub Fertility, Female, Fertility Disorders, Cycle Disorders Menstrual, Ovulation Disorder, Ovulation Absent, Ovulation Delayed
- Keywords
- fasting, natural therapies, caloric restriction, lifestyle modification, dietary restriction, dietary intervention, prolonged fasting, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 28 Jun 2021 (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.
This exploratory study investigates fasting as a potential supportive therapy in infertility treatment for women suffering from infertility
Detailed description
This 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a novel supportive treatment in infertility. The participants will be randomized in two groups: fasting and waiting list. All groups will be trained and accompanied by medical experts and dieticians. In addition, qualitative interviews will be conducted including individual and focus group interviews with a subgroup of participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are 2 parallel groups following different nutritional regimes. Additionally Qualitative Interviews with Patients and Doctors/Medical Staff.
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Behavioral: FastingParticipants will be councelled and accompanied to follow a prolonged fasting regime of 7-10 days in an outpatient setting under medical supervision. Additionally qualitative interviews will be conducted by few participants in the experimental arm, as well as their respective Healthcare Providers (Doctors/Medical Staff). |
| Control group | No intervention | –waiting list, usual diet should be maintained |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 25 to 45 years
- Unfulfilled desire to have children >1 year
- declaration of consent
- 20 kg/m² ≤ BMI ≤ 40 kg/m²
Key exclusion criteria (8 listed)
- Language barriers
- Previously known serious mental illness or cognitive impairment
- Patients with anatomical/organic damage and proven uterine abnormalities
- Eating disorders in the medical history
- Serious previous internal diseases
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 |
|---|---|---|
| FastingProlonged fasting for 7-10 days (caloric intake <500 kcal in liquid form) | Behavioural | Fasting |
Primary outcome
Qualitative interview analysis of fasting experience
Time frame: in time frame of 24 weeks after fasting intervention
individual and focus group interviews
pregancy rate
Time frame: at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline
pregnancy rate of the participants
23 secondary outcomes
complication rates in pregnancy
Time frame: 12 months after baseline
Hormonal status
Time frame: at the beginning and end of each ovulatory cycle, for up to 12 months
HbA1c
Time frame: baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months
WHO-5
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
diet
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
mindfulness
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
anxiety and depression
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
current mood
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
experienced stress
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
physical fitness
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
quality of relationship
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
psychological stress caused by the unfulfilled desire to have children
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
gratitude
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
self-efficacy
Time frame: at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline
abdominal ultrasound after liver wrap
Time frame: before, during and after the fasting intervention
rate of ovulations
Time frame: at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline
liver function parameters
Time frame: at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months
pyruvate in culture medium of oocytes, if applicable (in case of IVF/ICSI)
Time frame: after in vitro fertilisation, if applicable during study period of one year
glucose in culture medium of oocytes, if applicable (in case of IVF/ICSI)
Time frame: after in vitro fertilisation, if applicable during study period of one year
lactate in culture medium of oocytes, if applicable (in case of IVF/ICSI)
Time frame: after in vitro fertilisation, if applicable during study period of one year
Continuous Glucose Monitoring
Time frame: 14 days after baseline
Ketone bodies in breath
Time frame: up to 4 days before, during and up to 7 days after fasting intervention
Cumulative drug dose for ovulation induction
Time frame: baseline and until end of treatment for ovulation induction (2-6 months)
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 29 Dec 2023.
- Derived from this study: PubMed 42855686Behling JN, May KT, Batschari K, Sochiera-Plegniere K, Blakeslee SB, Stritter W, Jeitler M, Kandil FI, Kunz B, Pruss A, Michalsen A, Koppold DA. Women's experiences of a medically supervised fasting intervention for infertility: a qualitative study. BMC Womens Health. 2026 Oct 9;26(1):511. doi: 10.1186/s12905-026-04978-y.
- Individual participant dataSharing planned: Yes. Data will be made available upon request.
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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.
Andreas Michalsen, Prof. Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting in people with Sub Fertility, Female and Fertility Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.
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 4 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: finished, as of the sponsor's last update on 29 Dec 2023. 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 Germany. 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?
Qualitative interview analysis of fasting experience (time frame: in time frame of 24 weeks after fasting intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04942457, which also lists 1 linked publication.
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 29 Dec 2023.