Clinical trial NCT06910293: Whole-Brain Dynamics in the Natural Menstrual Cycle vs. an Ovarian Stimulated Cycle: Impact of Hormonal Fluctuations on Healthy Women Undergoing Ovarian Stimulation
Official title: Whole-Brain Dynamics in the Natural Menstrual Cycle vs. an Ovarian Stimulated Cycle: Impact of Hormonal Fluctuations on Healthy Women Undergoing Ovarian Stimulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neural Activity
Brain Function
Neurodynamics
Brain Connectivity
Keywords: Menstrual Cycle
Ovarian Stimulated Cycle
Endocrine Profile
neural activity
neurodynamics
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
Collaborators: name: Khalifa University for Science and Technology
name: New York University Abu Dhabi
First posted: 2025-04-04
Enrollment: 15
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young (age range 25-35), healthy, naturally cycling women with a normal BMI, who want to undergo ovarian stimulation for oocyte vitrification.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Brain activity using functional magnetic resonance imaging (fMRI).
timeFrame: Measure at three cycle points: basal (day 2-3), ovulation (during ovulation or day after trigger-shot), and at luteal phase (7-10 days after ovulation or trigger shot).
Secondary outcomes:
measure: Hormonal levels (Estradiol, LH, FSH, Progesterone) fluctuation.
timeFrame: Measure at three cycle points: basal (day 2-3), ovulation (during ovulation or day after trigger-shot), and at luteal phase (7-10 days after ovulation or trigger shot).
measure: Whole genome sequencing of patient.
timeFrame: Day 1 - baseline saliva sample collection.
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: ART Fertility Clinics LLC
city: Abu Dhabi
country: United Arab Emirates
facility: ART Fertility Clinics LLC
Study officials:
References:
citation: Mueller JM, Pritschet L, Santander T, Taylor CM, Grafton ST, Jacobs EG, Carlson JM. Dynamic community detection reveals transient reorganization of functional brain networks across a female menstrual cycle. Netw Neurosci. 2021 Feb 1;5(1):125-144. doi: 10.1162/netn_a_00169. eCollection 2021.
citation: Pritschet L, Santander T, Taylor CM, Layher E, Yu S, Miller MB, Grafton ST, Jacobs EG. Functional reorganization of brain networks across the human menstrual cycle. Neuroimage. 2020 Oct 15;220:117091. doi: 10.1016/j.neuroimage.2020.117091. Epub 2020 Jul 2.