ClinicalTrials.gg
RecruitingNCT06910293Updated Jun 23, 2026

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

An observational study in Neural Activity, Brain Function and Neurodynamics, sponsored by ART Fertility Clinics LLC. Recruiting at 2 sites in United Arab Emirates. Open to female participants aged 25 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by ART Fertility Clinics LLC · Observational

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
15
Ages
25 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Neural Activity
  • Brain Function
  • Neurodynamics
  • Brain Connectivity

Keywords

  • Menstrual Cycle
  • Ovarian Stimulated Cycle
  • Endocrine Profile
  • neural activity
  • neurodynamics
03

In context

Lead sponsor

ART Fertility Clinics LLC is the lead sponsor of 51 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age group: 25 - 35 years old
  • : 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 : of 3 month
  • Meet standard safety and eligibility criteria for MRI scanning, including the absence of such as metallic implants, claustrophobia, or other medical conditions that preclude MRI

Exclusion criteria

Exclusion Criteria:

  • History of ovarian surgery
  • Pathology of the ovaries
  • Mental health disorders
  • Use of medication influencing brain function
  • Ongoing use of hormonal (this would include OCP, but also patches and Mirena containing IUD)
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
15 participants (estimated)
Target follow-up
8 Weeks
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Diagnostic testFunctional 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.

06

What researchers measure

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.

    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).

Secondary outcomes

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

    Analyze relation of hormonal fluctuations (Estradiol, LH, FSH, Progesterone) at three cycle points with brain dynamics and neural connectivity.

    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).

  2. Whole genome sequencing of patient.

    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.

    Time frame: Day 1 - baseline saliva sample collection.

07

Study locations

2 of 2 sites recruiting
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References and documents

Publications

  • 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. PubMed 33688609 ↗
  • 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. PubMed 32621974 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2025 (actual). Primary completion is estimated for Dec 2026, 20 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2025
First posted
Apr 4, 2025
StartActual
Apr 7, 2025
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 31, 2026
Last update
Jun 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06910293
Lead sponsor
ART Fertility Clinics LLC
Collaborators
Khalifa University for Science and Technology, New York University Abu Dhabi
Responsible party
Dr. Raquel Del Gallego Bonilla (Head Clinical Data Management Unit, ART Fertility Clinics LLC) — Principal investigator
First posted
Apr 4, 2025
Start date
Apr 7, 2025
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 23, 2026

Study contacts

Raquel Del Gallego, PhD
Contact
raquel.delgallego@artfertilityclinics.com
+971 2 6528000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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