G43.0
Conditions
Interventions
Group 1: Women with migraine undergoing fertility treatment
(Prospective cohort study assessing microvascular function during ongoing fertility treatment)
Group 2: Women without migraine undergoing fe
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: General inclusion criteria (all participants) Current participation in an ongoing fertility treatment Additional inclusion criteria Arm 1 (Women with migraine): Confirmed diagnosis of episodic migraine according to the International Headache Society criteria (ICHD-3) 1 to 8 migraine days within the 28 days prior to study inclusion No ongoing preventive migraine medication Arm 2 (Women without migraine): No history of migraine or other chronic headache disorders
Exclusion criteria
Exclusion criteria: Presence of neurological disorders (e.g., multiple sclerosis, brain tumor, history of severe traumatic brain injury, history of neurosurgical intervention) Severe inflammatory diseases (infectious or rheumatologic) Arterial hypertension or pronounced arterial hypotension Cardiovascular diseases (e.g., cerebral ischemia, coronary artery disease, history of myocardial infarction, peripheral arterial disease, relevant valvular heart disease) Diabetes mellitus Body mass index (BMI) 30 kg/m² Alcohol or substance abuse Severe psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| What: Microvascular function (endothelial reactivity) When: Single assessment during ongoing fertility treatment, cycle day 9–14 of the stimulation cycle How: Assessment of dermal microvascular perfusion using laser speckle perfusion imaging (LSPI) following local thermal hyperemia; the primary parameter is the area under the curve (AUC) of perfusion over the entire measurement period. | — |
Secondary
| Measure | Time frame |
|---|---|
| What: Peak and plateau phases of the thermal hyperemia response, Hormonal, inflammatory and endothelial markers When: Single experimental visit (cycle day 9–14 of the stimulation cycle) How: LSPI-based analysis under standard conditions and after local pretreatment with lidocaine/prilocaine (EMLA®) Blood sampling for assessment of hormones, inflammatory parameters, endothelial markers Assessment of headache burden via clinical history | — |
Countries
Germany
Contacts
Public ContactBianca Raffaelli
Charité Universitätsmedizin Berlin
Outcome results
None listed