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

Recruiting

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

• Registration Number: NCT06910293
• Lead Sponsor: ART Fertility Clinics LLC

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.

Study Timeline

• Study First Submitted: 2025-03-10
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-02
• Study First Posted: 2025-04-04
• Study Start: 2025-04-07
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-10
• Primary Completion: 2026-04-05
• Study Completion: 2026-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 15

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain activity using functional magnetic resonance imaging (fMRI).	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).	Comparison of brain activity between the natural menstrual cycle and a stimulated cycles using functional magnetic resonance imaging (fMRI) at three cycle points.

Secondary Outcome Measures

Name	Time	Method
Hormonal levels (Estradiol, LH, FSH, Progesterone) fluctuation.	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).	Analyze relation of hormonal fluctuations (Estradiol, LH, FSH, Progesterone) at three cycle points with brain dynamics and neural connectivity.
Whole genome sequencing of patient.	Day 1 - baseline saliva sample collection.	Sequence patient's genome using saliva sampling to observes the genetic basis of fertility traits, to identify genetic variants associated with various neural and fertility phenotypes.

Trial Locations

Locations (1)

ART Fertility Clinics LLC; 🇦🇪 Abu Dhabi, United Arab Emirates