Whole-Brain Dynamics in the Natural Menstrual Cycle vs. an Ovarian Stimulated Cycle: Impact of Hormonal Fluctuations on Healthy Women Undergoing Ovarian Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Brain activity using functional magnetic resonance imaging (fMRI).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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)
- Basal (day 2-3 of the menstrual cycle)
- Monitoring of follicle growth (no fMRI at these monitoring dates)
- Day of LH surge +/-1 day (around day 14, 2-3 hormonal checks will be needed to identify Ovulation Day)
- 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.
干预措施: Functional Magnetic resonance imaging will be done on day 2 or 3 of the menstrual cycle, trigger-shot and egg retrieval. (Diagnostic Test)
结局指标
主要结局
Brain activity using functional magnetic resonance imaging (fMRI).
时间窗: 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.
次要结局
- 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.)
研究者
Dr. Raquel Del Gallego Bonilla
Head Clinical Data Management Unit
ART Fertility Clinics LLC