Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

All Drugs and Chemicals

Reproductive Control Agents

Hormones

Follicle Stimulating Hormone

Estropipate

Estrone

To characterize quantitative hormones in the urine using the Mira monitor, along with other menstrual cycle biomarkers, and validate these in reference to serum hormonal measurements and the gold-standard of the ultrasound-day of ovulation in participants with normal menstrual cycles (cycle length 24-38 days).

To identify hormonal and other menstrual cycle biomarker variations in polycystic ovarian syndrome (PCOS) with oligomenorrhea.

To identify hormonal and other menstrual cycle biomarker variations in oligomenorrheic athletes.

Using the Mira monitor to track the menstrual cycle

Mira Monitor tracking

Thomas P Bouchard, MD

Thomas Bouchard, MD

The Quantum Menstrual Health Monitoring Study will measure four key reproductive hormones in the urine to characterize patterns that predict and confirm ovulation, referenced to serum hormones and the gold-standard of the ultrasound day of ovulation in participants with regular cycles. These normal cycles will provide a reference for comparison to irregular cycles in polycystic ovarian syndrome (PCOS) and athletes. Clinical signs in the menstrual cycle (e.g. menstrual bleeding, temperature) as well as vital sign and sleep patterns will also be referenced to hormonal changes.

Quantum Menstrual Health Monitoring Study

Quantitative Hormonal Biomarkers of Menstrual Health in Normal and Abnormal Cycles

The LH surge on the Mira monitor will accurately predict ovulation within 1-2 days referenced to the ultrasound-day of ovulation

The progesterone (PDG) rise on the Mira monitor will accurately confirm ovulation within 3-5 days of the ultrasound-day of ovulation

FSH and E3G changes on the Mira monitor will predict the beginning of the fertile window

Menstrual bleeding scores, including heavy bleeding, will be indicative of abnormal conditions like PCOS and correlated with progesterone abnormalities

Temperature, like progesterone, will rise to confirm ovulation 3-5 days after the ultrasound-confirmed day of ovulation

Patricia Doyle-Baker

Quanovate Tech Inc.

Associate Professor

Immune System Diseases

Behaviors and Mental Disorders

Hypersensitivity

Quality of Life

Anti-Inflammatory Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

2 Hz EA during 30 minutes, twice a week, 14 weeks.

Low-frequency electro-acupuncture (EA)

Meeting a therapist, twice a week during 30 minutes in order to control for the increased amount of attention.

Meeting a therapist - attention control

Hypothesis The overall hypothesis is that non-obese (BMI \<30) women with PCOS have high luteinising hormone (LH) and cortisol pulse frequency and amplitude and that repeated low-frequency EA restore these alterations and induce ovulation.

Aim 1. Elucidate if low-frequency EA induce ovulation and restore LH frequency and amplitude as well as sex steroid secretion as compared to a control group receiving same amount of attention.

Aim 2. Elucidate if low-frequency EA restore cortisol frequency and amplitude compared to a control group receiving same amount of attention.

Aim 3. Elucidate if low-frequency EA restore psychological distress and quality of life as compared to a control group receiving same amount of attention.in women with PCOS.

Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome

Does Low-frequency Electro-acupuncture Restore Sensitivity of the Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome

Göteborg University

Antineoplastic Agents

Androgens

Testosterone

Flutamide

Androgen Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Flutamide 250 mg taken by mouth twice a day for 4 weeks. Flutamide is an androgen-receptor blocker.

Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.

Flutamide, 250 mg capsule for oral administration, twice a day for 4 weeks (or menstrual cycle length in normally-cycling controls)

Placebo, for oral administration, twice a day for 4 weeks (or menstrual cycle length in normally-cycling controls)

Placebo

Christopher R McCartney, MD

The purpose of this study is to determine whether a testosterone receptor blocker (flutamide) will normalize sleep-wake luteinizing hormone pulse frequency relationships in women with polycystic ovary syndrome.

During the follicular phase of the normal menstrual cycle, luteinizing hormone (LH) pulse frequency decreases during sleep. These decreases may be important to support follicle stimulating hormone (FSH) synthesis and secretion. Polycystic ovary syndrome (PCOS) is associated with a persistently rapid gonadotropin hormone-releasing hormone (GnRH) pulse frequency, an abnormality that may account for many of the hormonal manifestations of PCOS. Although one prior study suggests that nocturnal LH frequency decreases slightly in PCOS, methodological issues limit interpretation. Our preliminary data suggest that nocturnal LH frequency does not decrease in untreated PCOS, but that nocturnal decreases of LH frequency are restored with androgen receptor blockade (flutamide) in women with PCOS. We have two hypotheses: (1) Prior to flutamide administration, sleep-associated slowing of LH pulse frequency is less pronounced in women with PCOS compared to that of normally-cycling women in the late follicular phase of the menstrual cycle; (2) After 4 weeks of flutamide administration, sleep-associated LH frequency reduction in women with PCOS is similar to that of normally-cycling women in the late follicular phase of the menstrual cycle. Women with PCOS and normally-cycling women will be studied. For each study participant, LH pulse frequency will be determined (from 1500 to 0700 h) after 4 weeks of flutamide and after 4 weeks of placebo. Flutamide and placebo will be given in random order (i.e., cross-over study). Sleep will be formally evaluated. Flutamide will then be given for 4 weeks prior to reassessment of LH pulse frequency. LH pulse frequency will be analyzed by way of hierarchical mixed effect models. We will use statistical analyses to determine: (a) whether the wake vs. sleep difference in LH frequency is the same for PCOS and normal controls prior to flutamide, and (b) whether the mean wake vs. sleep difference in LH frequency is the same for the two groups after flutamide.

Randomized, placebo-controlled, crossover study

Effect of High Testosterone on Sleep-associated Slowing of Follicular Luteinizing Hormone (LH) Frequency in Polycystic Ovary Syndrome

Influence of Hyperandrogenemia on the Sleep-associated Slowing of Follicular LH Frequency in Adult Polycystic Ovary Syndrome

We do not have current plans to share IPD

Sleep study parameters (sleep stage, overnight ventilatory variables) will be assessed when available

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quantum Menstrual Health Monitoring Study	NCT05936840	Menstrual Cycle... Polycystic Ovar... Athletes	Mira Monitor tr...	18 Years - 55 Years	Quanovate Tech Inc.
Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome	NCT00921492	Polycystic Ovar...	Low-frequency e... Meeting a thera...	18 Years - 39 Years	Göteborg University
Quantum Menstrual Health Monitoring Study	NCT05936840	Menstrual Cycle... Polycystic Ovar... Athletes	Mira Monitor tr...	18 Years - 55 Years	Quanovate Tech Inc.
Effect of High Testosterone on Sleep-associated Slowing of Follicular Luteinizing Hormone (LH) Frequency in Polycystic Ovary Syndrome	NCT00930228	Polycystic Ovar...	Flutamide Placebo	18 Years - 35 Years	University of Virginia
Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome	NCT00921492	Polycystic Ovar...	Low-frequency e... Meeting a thera...	18 Years - 39 Years	Göteborg University
Quantum Menstrual Health Monitoring Study	NCT05936840	Menstrual Cycle... Polycystic Ovar... Athletes	Mira Monitor tr...	18 Years - 55 Years	Quanovate Tech Inc.

Spots Global Cancer Trial Database for luteinizing hormone