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

June 9, 2025 updated by: Dr. Raquel Del Gallego Bonilla, ART Fertility Clinics LLC
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Day 1 - baseline saliva sample collection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Collaborators

Khalifa University for Science and Technology
New York University Abu Dhabi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Estimated)

April 5, 2026

Study Completion (Estimated)

December 5, 2026

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22502-ABU-006-RDG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Connectivity

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe