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Completed

NCT Number: NCT04942457

Feasibility and Safety of Fasting in Fertility Treatment

This exploratory study investigates fasting as a potential supportive therapy in infertility treatment for women suffering from infertility

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Key information

Conditions

Sub Fertility, Female Adnexal Diseases Anovulation Behavior Body Weight Body Weight Changes Cycle Disorders Menstrual Endocrine System Diseases Fasting Feeding Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fertility Disorders Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Infertility, Female Menstruation Disturbances Ovarian Diseases Ovulation Absent Ovulation Delayed Ovulation Disorder Ovulation; Failure or Lack of Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Sub-Fertility Urogenital Diseases Weight Loss

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin

Berlin, 14109, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 25 to 45 years
  • Unfulfilled desire to have children >1 year
  • declaration of consent
  • 20 kg/m² ≤ BMI ≤ 40 kg/m²

Exclusion criteria

  • 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

Treatment and study plan

Fasting

Behavioral

Prolonged fasting for 7-10 days (caloric intake <500 kcal in liquid form)

Primary outcomes

  1. Qualitative interview analysis of fasting experience

    Time frame: in time frame of 24 weeks after fasting intervention

    individual and focus group interviews

  2. 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

Secondary outcomes

  1. complication rates in pregnancy

    Time frame: 12 months after baseline

    complication rates monitored by the gynaecologist, if applicable

  2. Hormonal status

    Time frame: at the beginning and end of each ovulatory cycle, for up to 12 months

    FSH, LH, Estrogen, Progesteron

  3. HbA1c

    Time frame: baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months

    serum parameter

  4. 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

    Quality of life

  5. 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

    questionnaire to examine dietary behaviour

  6. 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

    MAAS-questionnaire, validated questionnaire to examine mindfulness

  7. 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

    HADS-questionnaire, validated questionnaire to examine anxiety and depression

  8. 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

    ASTS-questionnaire, validated questionnaire to examine current mood

  9. 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

    Cohen-stress scale, validated questionnaire to examine experienced stress

  10. 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

    questionnaire to examine physical fitness

  11. 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

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

  12. 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

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

  13. 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

    validated questionnaire to examine gratitude

  14. 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

    ASKU, validated questionnaire to examine self-efficacy

  15. abdominal ultrasound after liver wrap

    Time frame: before, during and after the fasting intervention

    sonography in a subgroup

  16. rate of ovulations

    Time frame: at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline

    ovulation visible in sonography

  17. liver function parameters

    Time frame: at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months

    serum liver enzymes

  18. 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

    chemical composition of culture medium (pyruvate)

  19. 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

    chemical composition of culture medium (glucose)

  20. 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

    chemical composition of culture medium (lactate)

  21. Continuous Glucose Monitoring

    Time frame: 14 days after baseline

    Continuous Glucose Monitoring via CGM-Device in subgroup

  22. Ketone bodies in breath

    Time frame: up to 4 days before, during and up to 7 days after fasting intervention

    Breath acetone, in subgroup

  23. Cumulative drug dose for ovulation induction

    Time frame: baseline and until end of treatment for ovulation induction (2-6 months)

    Cumulative dosage of hormonal therapy for each assisted cycle of ovulation induction

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Karl and Veronica Carstens Foundation

Registry information

Official study title

Effects of Fasting in Fertility Treatment in Women

Acronym: KiWuA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2021
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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