Whole-brain activity during a natural menstrual cycle versus an ovarian stimulation cycle
Whole-Brain Dynamics in the Natural Menstrual Cycle vs. an Ovarian Stimulated Cycle: Impact of Hormonal Fluctuations on Healthy Women Undergoing Ovarian Stimulation
ART Fertility Clinics LLC · NCT06910293
This research will test whether hormonal changes from ovarian stimulation change resting brain activity in healthy young women with regular cycles.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 25 Years to 35 Years |
| Sex | Female |
| Sponsor | ART Fertility Clinics LLC (other) |
| Locations | 2 sites (Abu Dhabi, Abu Dhabi Emirate and 1 other locations) |
| Trial ID | NCT06910293 on ClinicalTrials.gov |
What this trial studies
This observational study uses resting-state fMRI to compare whole-brain dynamic complexity at three matched timepoints in each woman during a natural menstrual cycle and during a controlled ovarian stimulation cycle. Participants will be scanned on cycle day 2–3 (basal/early follicular), at the trigger-shot/pre-OPU (pre-ovulatory), and in the mid-luteal phase for both cycles, and blood hormone levels will be collected. Within-subject comparisons will link endocrine profiles to measures of brain connectivity and neurodynamics. The protocol focuses on young, healthy, naturally cycling women to isolate the effects of externally administered stimulation hormones.
Who should consider this trial
Good fit: Ideal candidates are healthy women aged 25–35 with BMI 20–30, AMH 1.3–5.9 ng/ml, regular 26–35 day cycles, MRI eligibility, and at least a 3-month washout if previously on hormonal contraception.
Not a fit: Women with prior ovarian surgery, ovarian pathology, current hormonal contraception, mental health disorders, or use of medications that influence brain function are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could clarify whether ovarian stimulation alters brain activity and help inform safety information and counseling for women undergoing fertility treatments.
How similar studies have performed: This approach is largely novel, as few prior studies have directly compared whole-brain dynamics during ovarian stimulation versus natural cycles using resting-state fMRI.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Abu Dhabi, Abu Dhabi Emirate and 1 other locations
- ART Fertility Clinics LLC — Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates (RECRUITING)
- ART Fertility Clinics LLC — Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates (RECRUITING)
Study contacts
- Study coordinator: Raquel Del Gallego, PhD
- Email: raquel.delgallego@artfertilityclinics.com
- Phone: +971 2 6528000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neural Activity, Brain Function, Neurodynamics, Brain Connectivity, Menstrual Cycle, Ovarian Stimulated Cycle, Endocrine Profile, neural activity