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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age25-35
SponsorART Fertility Clinics LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

History of ovarian surgery

Pathology of the ovaries

Mental health disorders

Use of medication influencing brain function

Trial population

Young (age range 25-35), healthy, naturally cycling women with a normal BMI, who want to undergo ovarian stimulation for oocyte vitrification.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Young (age range 25-35), healthy , who want to undergo ovarian stimulation for oocyte vitrification.1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ART Fertility Clinics LLC

Lead sponsor

Khalifa University for Science and Technology

Collaborator

New York University Abu Dhabi

Collaborator