Neural ActivityNCT06910293
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 of Neural Activity and Brain Function, run by ART Fertility Clinics LLC at 2 sites in United Arab Emirates.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neural Activity, Brain Function, Neurodynamics
- What is being tested?
- Functional Magnetic resonance imaging will be done on day 2 or 3 of the menstrual cycle, trigger-shot and egg retrieval.
- How many people
- 15 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 7 Apr 2025to 31 Dec 2026
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Young (age range 25-35), healthy, naturally cycling women with a normal BMI, who want to undergo ovarian stimulation for oocyte vitrification.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates2 sites, 2 recruiting
- Recruiting
ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, 00000
Jonalyn Edades, Research Coordinator, +97126528000, jonalyn.edades@artfertilityclinics.com
- Recruiting
ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, 60202
Jonalyn Edades, Research Coordinator, +97126528000, jonalyn.edades@artfertilityclinics.com
About this study
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.
- Conditions
- Neural Activity, Brain Function, Neurodynamics, Brain Connectivity
- Being tested
- Functional Magnetic resonance imaging will be done on day 2 or 3 of the menstrual cycle, trigger-shot and egg retrieval.
- Keywords
- Menstrual Cycle, Ovarian Stimulated Cycle, Endocrine Profile, neural activity, neurodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Functional Magnetic resonance imaging will be done on day 2 or 3 of the menstrual cycle, trigger-shot and egg retrieval. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Analyze relation of hormonal fluctuations (Estradiol, LH, FSH, Progesterone) at three cycle points with brain dynamics and neural connectivity.
Measured: 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.
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.
Measured: Day 1 - baseline saliva sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start7 Apr 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neural ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Khalifa University for Science and Technology, New York University Abu Dhabi
- Responsible party
- Principal investigator, Dr. Raquel Del Gallego Bonilla, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910293
- Sponsor's protocol ID
- 22502-ABU-006-RDG
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 33688609Pritschet 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-Brain Dynamics in the Natural Menstrual Cycle vs. an Ovarian Stimulated Cycle: Impact of Hormonal Fluctuations on Healthy Women Undergoing Ovarian Stimulation
- ClinicalTrials.gov ID
- NCT06910293
- Acronym / sponsor ID
- 22502-ABU-006-RDG
- Conditions
- Neural Activity, Brain Function, Neurodynamics, Brain Connectivity
- Keywords
- Menstrual Cycle, Ovarian Stimulated Cycle, Endocrine Profile, neural activity, neurodynamics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Collaborators
- Khalifa University for Science and Technology, New York University Abu Dhabi
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young (age range 25-35), healthy , who want to undergo ovarian stimulation for oocyte vitrification. | – | Diagnostic Test: Functional Magnetic resonance imaging will be done on day 2 or 3 of the menstrual cycle, trigger-shot and egg retrieval.- 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. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young (age range 25-35), healthy, naturally cycling women with a normal BMI, who want to undergo ovarian stimulation for oocyte vitrification.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Young (age range 25-35), healthy , who want to undergo ovarian stimulation for oocyte vitrification. |
Primary outcome
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.
2 secondary outcomes
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).
Whole genome sequencing of patient.
Time frame: Day 1 - baseline saliva sample collection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 33688609Mueller 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.
- Background: PubMed 32621974Pritschet 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.
Related trials for Neural Activity
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
RecruitingPhase 2
Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS
Parkinson's Disease, Deep Brain Stimulation
Recruiting
Walking Sensation Study
Aging, Sensory Deficit
Not yet recruiting
Measurement of Efferent Neural Drive From Respiratory Centers to Upper Airways Using Electromyography (EMG) of Genioglossus (GG) in Patients Dependent on Invasive Mechanical Ventilation
Invasive Mechanical Ventilation, Extubation Time
Recruiting
A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neural Activity and Brain Function, run by ART Fertility Clinics LLC at 2 sites in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raquel Del Gallego, PhD (+971 2 6528000, raquel.delgallego@artfertilityclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06910293, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.