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NCT Number: NCT06910293

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

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.

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Key information

Conditions

Neural Activity Brain Connectivity Brain Function Neurodynamics

Age range

25 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

ART Fertility Clinics LLC, Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

  1. Brain activity using functional magnetic resonance imaging (fMRI).

    Time frame: 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 outcomes

  1. Hormonal levels (Estradiol, LH, FSH, Progesterone) fluctuation.

    Time frame: 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.

  2. Whole genome sequencing of patient.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Raquel Del Gallego, PhD

CONTACT

[email protected]

+971 2 6528000

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Collaborators

  • Khalifa University for Science and Technology
  • New York University Abu Dhabi

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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