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Sub Fertility, FemaleKiWuCNCT04998591

Effects of Fasting on Success Rates of Assisted Reproductive Techologies

A study testing Fasting in people with Sub Fertility, Female and Fertility Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This exploratory study investigates fasting as a potential supportive therapy for infertility treatment in women undergoing in-vitro-fertilization (IVF) / intracystoplamsatic sperm injection (ICSI) Read more about this study

Who is it for?
Ages 25 to 38 years, women only
What is being tested?
Fasting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteGermany
Study dates
3 Aug 2021to 12 Dec 2022
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 38 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women aged 25 to 38 years with planned IVF / ICSI
  • 1 ng/ml ≤ Anti-Mullerian Hormone (AMH) ≤ 4 ng/ml
  • Unfulfilled desire to have children >1 year
  • 25 kg/m² ≤ BMI ≤ 35 kg/m² declaration of consent

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

Other trials in Germany

About this study

Official title: Effects of Fasting on Success Rates of In-vitro-fertilization (IVF) / Intracytoplasmatic Sperm Injection (ICSI) in Women With Fertility Disorders

This exploratory study investigates fasting as a potential supportive therapy for infertility treatment in women undergoing in-vitro-fertilization (IVF) / intracystoplamsatic sperm injection (ICSI)

Read the detailed description

This 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a novel supportive treatment in female infertility during IVF / ICSI. The participants will be randomized in two groups: a fasting group and a waiting list. The intervention group follows a fasting intervention, whereas the patients on the waiting list continue their normal diet. All groups will be trained and accompanied by medical experts. In addition, qualitative interviews will be conducted including individual and focus group interviews with a subgroup of participants.

Being tested
Fasting
Keywords
fasting, natural therapies, caloric restriction, lifestyle modification, dietary restriction, dietary intervention, complementary medicine, integrative medicine, Intracytoplasmatic sperm injection ICSI
Medical subject headings
Infertility, Female, Infertility, Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FastingBehavioural

    Also called Prolonged Fasting

    fasting for 7 days (caloric intake <500 kcal in liquid form)

Study groups in NCT04998591
Study groupRoleWhat they receive
Fasting groupExperimentalParticipants will be councelled and accompanied to follow a fasting regime of 7 days in an outpatient setting under medical supervision.
Receives: Behavioral: Fasting
Waiting listNo interventionThis group maintains their individual diet during the whole time of the study. In case that the first cycle of In-Vitro-Fertilization fails, they are offered a fasting intervention before a next cycle.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fertilisation rate

    Fertilisation rate of the retrieved oocytes

    Measured: throughout 1-3 days after in-vitro-fertilization (IVF) / intracytoplasmatic sperm injection (ICSI)

Secondary outcomes (20)

  1. glucose in culture medium of oocytes

    chemical composition of culture medium (glucose)

    Measured: throughout 1-3 days after in vitro fertilisation

  2. lactate in culture medium of oocytes

    chemical composition of culture medium (lactate)

    Measured: throughout 1-3 days after in vitro fertilisation

  3. pyruvate in culture medium of oocytes

    chemical composition of culture medium (pyruvate)

    Measured: throughout 1-3 days after in vitro fertilisation

  4. pregnancy rate

    pregnancies after IVF/ICSI

    Measured: 4 weeks after IVF/ICSI

  5. rate of mature oocytes

    rate of mature oocytes

    Measured: at IVF / ICSI intervention

  6. rate of life births

    rate of life births after IVF/ICSI

    Measured: 10 months after IVF/ICSI

  7. rate of implantable embryos

    rate of implantable embryos after the IVF/ICSI

    Measured: at IVF/ICSI

  8. Course of IVF/ICSI preparation and pregnancy

    Course of IVF/ICSI preparation and pregnancy

    Measured: 4 weeks and 10 months after IVF / ICSI

  9. WHO-5 questionnaire

    Quality of life

    Measured: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline

  10. changes in diet

    self-developed questionnaire to examine dietary behaviour

    Measured: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline

  11. mindfulness

    MAAS-questionnaire, validated questionnaire to examine mindfulness

    Measured: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline

  12. anxiety and depression

    HADS-questionnaire, validated questionnaire to examine anxiety and depression

    Measured: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline

  13. current mood

    ASTS-questionnaire, validated questionnaire to examine current mood

    Measured: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline

  14. experienced stress

    Cohen-stress scale, validated questionnaire to examine experienced stress

    Measured: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline

  15. physical fitness

    questionnaire to examine physical fitness

    Measured: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline

  16. quality of relationship

    self-developed questionnaire to examine the relationship between the two partners desiring to have a child

    Measured: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline

  17. psychological stress caused by the unfulfilled desire to have children

    self-developed questionnaire to examine the psychological stress caused by the unfulfilled desire to have children

    Measured: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline

  18. gratitude

    validated questionnaire to examine gratitude

    Measured: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline

  19. self-efficacy

    ASKU, validated questionnaire to examine self-efficacy

    Measured: baseline, within one week before IVF, 4 weeks after IVF, 10 months after baseline

  20. abdominal sonography

    sonography in a subgroup

    Measured: within 1 month before, during and within 2 weeks after the fasting intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2021
  2. Study start3 Aug 2021
  3. Primary completion12 Dec 2022
  4. Study completion12 Dec 2022

Why it stopped: Recruitment difficulties

Resources

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
This explorative study is conducted in form of a randomized, controlled trial design with a fasting intervention and a waiting list, which continues the usual diet.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04998591
Sponsor's protocol ID
KiWuC
Acronym
KiWuC
Status last verified
Dec 2022
First submitted
24 Jul 2021
Last updated
14 Dec 2022
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.

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: stopped early, as of the sponsor's last update on 14 Dec 2022. 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 was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.

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?

Fertilisation rate (time frame: throughout 1-3 days after in-vitro-fertilization (IVF) / intracytoplasmatic sperm injection (ICSI)). 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 NCT04998591.

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 14 Dec 2022.

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