PCOS Clinical Trial
Official title:
Administration of Kisspeptin to Subjects With Reproductive Disorders
The goal of this study is to learn about the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that causes the release of other hormones, including gonadotropin-releasing hormone (GnRH) in the body.
Status | Recruiting |
Enrollment | 496 |
Est. completion date | August 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | A. Healthy Subjects All healthy subjects will meet the following criteria: - normal puberty with respect to onset and pace, - no chronic diseases, - no difficulty with blood draws, - no prescription medications for at least 2 months with the exception of seasonal allergy medications and hormone replacement therapy, - no illicit drug use or excessive alcohol consumption (< 10 drinks/week), - no history of a medication reaction requiring emergency medical care, - normal physical exam and laboratory studies within protocol reference ranges. Additional criteria based on subject population: 1. Healthy Men: - between 21 and 40 years old, - normal erectile and ejaculatory function, no history of reproductive disorders, - testicular volume >15 ml. 2. Healthy women: - between 21 and 40 years old, - not breastfeeding or pregnant, - menstrual cycles between 25 and 35 days in duration, at least 11 periods/year, with no more than 5 days variability in cycle duration, - no evidence for androgen excess (hirsutism or acne), - at screening, negative hCG pregnancy test, - negative screening for Factor V Leiden for those who might receive estradiol treatment as a part of this study. 3. Healthy postmenopausal women: - between 50 and 60 years old, - no menstrual periods within the last year, - previous history of menstrual cycles between 25 and 35 days in duration, with no more than 5 days variability in cycle duration, - if applicable, able to undergo washout from hormone therapy, - no evidence for androgen excess (hirsutism or acne), - negative screening for Factor V Leiden for those who might receive estradiol treatment as a part of this study. B. Subjects with Reproductive Disorders All subjects with reproductive disorders will meet the following criteria: - 18 years or older, - all medical conditions stable and well controlled, - no prescription medications known to affect reproductive endocrine function for at least 2 months except for medications used to treat the subject's reproductive condition, - no history of a medication reaction requiring emergency medical care, - no illicit drug use or excessive alcohol consumption (<10 drinks/week), - for women, not breastfeeding or pregnant, - if applicable, able to undergo appropriate washout from hormone therapy, - normal physical exam and laboratory studies within protocol reference ranges, - for women, at time of screening negative hCG pregnancy test. Additional criteria based on subject population: 1. Men and women with hypogonadotropic hypogonadism, - Confirmed diagnosis by low sex steroids in the setting of low or inappropriately normal gonadotropins, - If needed, additional labs and imaging tests may be performed. 2. Women with Polycystic Ovarian Syndrome (PCOS) - Confirmed diagnosis of PCOS, - If needed, additional labs and imaging tests may be performed. 3. Men and women with hyperprolactinemia - confirmed diagnosis of elevated levels of prolactin measured via blood test, - no pituitary adenoma OR a microprolactinoma (<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded, - willing to complete a dopamine agonist washout. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average change in luteinizing hormone (LH) in response to kisspeptin | Within 30 minutes of administration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06101147 -
Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome
|
Phase 2 | |
Completed |
NCT02037672 -
PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome
|
Phase 4 | |
Completed |
NCT01833949 -
Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume
|
N/A | |
Completed |
NCT03608813 -
Myo-inositol, D-chiro-inositol and Glucomannan in PCOS
|
||
Not yet recruiting |
NCT05298657 -
The Angiotensin-Melatonin Axis in Poor and Hyper Responders for IVF Treatment
|
||
Completed |
NCT05951309 -
Myoinositol Treatment and Asprosin Levels in PCOS
|
N/A | |
Enrolling by invitation |
NCT04485403 -
The Effect of Ibuprofen on Women With PCOS.
|
Phase 2 | |
Not yet recruiting |
NCT03978013 -
Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment
|
N/A | |
Recruiting |
NCT03767569 -
Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients
|
Phase 3 | |
Completed |
NCT05843955 -
Non-alcoholic Fatty Liver Disease in Women With Polycystic Ovary Syndrome
|
||
Recruiting |
NCT05971849 -
Dampening the Reproductive Axis With Continuous Kisspeptin
|
Phase 1 | |
Recruiting |
NCT04597099 -
Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion
|
Early Phase 1 | |
Active, not recruiting |
NCT05206448 -
Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation
|
Phase 4 | |
Recruiting |
NCT02358421 -
Prediction of High Ovarian Response After Assisted Reproductive Techniques
|
N/A | |
Completed |
NCT04113889 -
Effects of Triple Drug Cocktail Therapy on Metabolic, Endocrine Alterations and Perceived Stress in Patients With Poly Cystic Ovary Syndrome
|
Phase 2 | |
Completed |
NCT04562883 -
Single vs. Group CAPA-IVM Culture of Cumulus-oocyte Complexes
|
N/A | |
Recruiting |
NCT03264638 -
A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of PCOS
|
Phase 2 | |
Completed |
NCT00594217 -
Determining How Quickly Progesterone Slows LH Pulse Frequency
|
Phase 1 | |
Recruiting |
NCT02024984 -
Luteal Phase Versus Follicular Phase Administration of Clomiphene Citrate in PCOS, A Randomized Controlled Trial
|
Phase 1 | |
Completed |
NCT01709942 -
Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)
|
Phase 3 |