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

NCT06910293 | Recruiting

• 1 other identifier: 22502-ABU-006-RDG
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Neural Activity; Brain Function; Neurodynamics; Brain Connectivity

Keywords

Menstrual Cycle; Ovarian Stimulated Cycle; Endocrine Profile; neural activity; neurodynamics

Outcome Measures

Primary Outcomes (1)

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

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

  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 (2)

• 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).

• Whole genome sequencing of patient.

  Day 1 - baseline saliva sample collection.

Study Arms (1)

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

\- 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.

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

Interventions

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.

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

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: Only naturally cycling women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead
• Khalifa University for Science and Technology: collaborator
• New York University Abu Dhabi: collaborator

Study Sites (2)

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, 00000, United Arab Emirates

RECRUITING

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

RECRUITING

Related Publications (2)

• 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.

  PMID: 33688609 BACKGROUND

• 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.

  PMID: 32621974 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The first visit will include an additional genetic testing, to perform association analysis between genetic and neuroimaging and fertility data. The investigator will collect saliva samples from the study participants during their visit to NYUAD using a standard saliva collection kit. Samples will be stored on the facility freezers.

Central Study Contacts

Raquel Del Gallego, PhD

CONTACT

+971 2 6528000; raquel.delgallego@artfertilityclinics.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Clinical Data Management Unit

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: April 4, 2025
• Study Start: April 7, 2025
• Primary Completion: April 5, 2026
• Study Completion (Estimated): December 5, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-04

Locations

AE (2)