Cycle Disorders Menstrual, Fertility Disorders, Ovulation Absent, Ovulation Delayed, Ovulation Disorder, Ovulation; Failure or Lack of, Sub-fertility, Sub Fertility, Female
Conditions
Keywords
fasting, natural therapies, caloric restriction, lifestyle modification, dietary restriction, dietary intervention, prolonged fasting, weight loss, complementary medicine, integrative medicine
Brief summary
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.
Interventions
BEHAVIORALFasting
Prolonged fasting for 7-10 days (caloric intake \<500 kcal in liquid form)
Sponsors
Karl and Veronica Carstens Foundation
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
It is not possible to mask a fasting intervention for the participant or the study personel. Therefore only outcome assessors are masked.
Intervention model description
There are 2 parallel groups following different nutritional regimes. Additionally Qualitative Interviews with Patients and Doctors/Medical Staff.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative interview analysis of fasting experience | in time frame of 24 weeks after fasting intervention | individual and focus group interviews |
| pregancy rate | 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
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months | serum parameter |
| WHO-5 | 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 |
| diet | 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 |
| mindfulness | 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 |
| anxiety and depression | 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 |
| current mood | 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 |
| experienced stress | 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 |
| physical fitness | 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 |
| quality of relationship | 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 |
| psychological stress caused by the unfulfilled desire to have children | 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 |
| complication rates in pregnancy | 12 months after baseline | complication rates monitored by the gynaecologist, if applicable |
| self-efficacy | 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 |
| abdominal ultrasound after liver wrap | before, during and after the fasting intervention | sonography in a subgroup |
| rate of ovulations | at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline | ovulation visible in sonography |
| liver function parameters | at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months | serum liver enzymes |
| pyruvate in culture medium of oocytes, if applicable (in case of IVF/ICSI) | after in vitro fertilisation, if applicable during study period of one year | chemical composition of culture medium (pyruvate) |
| glucose in culture medium of oocytes, if applicable (in case of IVF/ICSI) | after in vitro fertilisation, if applicable during study period of one year | chemical composition of culture medium (glucose) |
| lactate in culture medium of oocytes, if applicable (in case of IVF/ICSI) | after in vitro fertilisation, if applicable during study period of one year | chemical composition of culture medium (lactate) |
| Continuous Glucose Monitoring | 14 days after baseline | Continuous Glucose Monitoring via CGM-Device in subgroup |
| Ketone bodies in breath | up to 4 days before, during and up to 7 days after fasting intervention | Breath acetone, in subgroup |
| Cumulative drug dose for ovulation induction | baseline and until end of treatment for ovulation induction (2-6 months) | Cumulative dosage of hormonal therapy for each assisted cycle of ovulation induction |
| gratitude | 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 |
| Hormonal status | at the beginning and end of each ovulatory cycle, for up to 12 months | FSH, LH, Estrogen, Progesteron |
Countries
Germany
Outcome results
None listed