Whole-Brain Dynamics in the Natural Menstrual Cycle vs. an Ovarian Stimulated Cycle: Impact of Hormonal Fluctuations on Healthy Women Undergoing Ovarian Stimulation

ART Fertility Clinics LLC

Status: Enrolling

Conditions: Neurodynamics; Neural Activity; Brain Function; Brain Connectivity

Treatments: Diagnostic Test: Functional Magnetic resonance imaging will be done on day 2 or 3 of the menstrual cycle, trigger-shot and egg retrieval.

Study type: Observational

Funder types: Other

Identifiers

NCT06910293

22502-ABU-006-RDG

Details and patient eligibility

About

The investigators aim is to investigate the brain's dynamic complexity across three phases of an ovarian stimulation cycle (basal, pre-OPU, mid-luteal), to observe the impact of externally administered hormones, and compare it with the corresponding phases of a natural menstrual cycle (early follicular, pre-ovulatory, mid-luteal) in the same woman. Brain activity patterns will be examined using resting-state fMRI in a sample of young, healthy, naturally cycling women.

Full description

The investigators seeks to fill a significant gap in our understanding of the impact of ovarian stimulation on brain dynamics, an area that has not been previously explored. By investigating the brain's dynamic complexity across controlled ovarian stimulation cycle the investigators aim to shed light on how externally administered hormones influence brain activity patterns. Utilizing resting-state Functional Magnetic Resonance Imaging to examine a sample of young, healthy, naturally cycling women, this research will provide crucial insights into the safety and neurophysiological effects of ovarian stimulation. Understanding these effects is essential for ensuring the well-being of women undergoing oocyte freezing and other fertility treatments.

Enrollment: 15 estimated patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age group: 25 - 35 years old
• BMI: 20 - 30
• Anti-Mullerian Hormone (AMH): 1.3 - 5.9 ng/ml
• Regular Menstrual Cycle: 26-35 days
• In case of previous use of hormonal contraception: wash-out period of 3 month
• Meet standard safety and eligibility criteria for MRI scanning, including the absence of contraindications such as metallic implants, claustrophobia, or other medical conditions that preclude MRI

Exclusion criteria

• History of ovarian surgery
• Pathology of the ovaries
• Mental health disorders
• Use of medication influencing brain function
• Ongoing use of hormonal contraception (this would include OCP, but also patches and Mirena containing IUD)

Trial design

15 participants in 1 patient group

Young (age range 25-35), healthy , who want to undergo ovarian stimulation for oocyte vitrification.

Description:

- Initial Assessment of Volunteers for Inclusion in the study. Once included, volunteers will need to be assessed 8 times during the study period, with 6 fMRI scans: * Natural menstrual cycle (depending on cycle duration: around 26-35 days) 1. Basal (day 2-3 of the menstrual cycle) 2. Monitoring of follicle growth (no fMRI at these monitoring dates) 3. Day of LH surge +/-1 day (around day 14, 2-3 hormonal checks will be needed to identify Ovulation Day) 4. Mid-Luteal (6-7 days after ovulation) * Stimulated Cycle 5. Basal (day 2-3 of the menstrual cycle) 6. Standard monitoring during ovarian stimulation (no fMRI at these monitoring dates) 7. Day between administration of final oocyte maturation \& Oocyte Pick-Up (OPU) 8. Mid-luteal (6-7 days after OPU) Every stage will include a blood test for hormonal evaluation, vaginal ultrasound for follicular count \& sizing, administration of MRI protocol. The first visit will include buccal swab.

Treatment:

Diagnostic Test: Functional Magnetic resonance imaging will be done on day 2 or 3 of the menstrual cycle, trigger-shot and egg retrieval.