Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Overweight

Obesity

Polycystic Ovary Syndrome

Overnutrition

Nutrition Disorders

Body Weight

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

Hypoglycemic Agents

All Drugs and Chemicals

Reproductive Control Agents

Anti-Obesity Agents

Antineoplastic Agents

Gastrointestinal Agents

Metformin

Liraglutide

Glucagon-Like Peptide-1 Receptor Agonists

Glucagon-Like Peptide 1

Contraceptive Agents

Exenatide

Contraceptives, Oral

Cyproterone Acetate

Cyproterone

Glucagon

Incretins

Hormones

Hormone Antagonists

Contraceptive Agents, Female

Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks.

Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks.

metformin oral with exenatide/liraglutide subcutaneous injection.

Metformin-GLP-1 Receptor Agonist

Metformin-Oral Contraceptive(OC)

Min long, MD

Polycystic ovary syndrome (PCOS) is a health problem that affects one in 10 women of childbearing age, which is usually characterized by hormonal imbalance and metabolism problems such as hyperandrogenism and obesity. Diane 35 pills are classified as oral contraceptives, which effectively reduces circulating androgens and are treatment for hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. GLP-1 Receptor Agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and weight control by inhibiting of gastric emptying and reducing food intake. This study aims to evaluate the effect of metformin-GLP-1 Receptor agonist combination versus metformin-Diane-35 combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic ovarian syndrome (PCOS) patients.

Groups:

Experimental treatment: Metformin-GLP-1 Receptor Agonist Therapy.

Regular treatment: Metformin-Oral Contraceptive(OC) Therapy.

Time Point:

Initial treatment;

Post-treatment (4w);

Post-treatment (8w);

Post-treatment (12w);

Assess reproductive functions and cardiovascular risk factors.

The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS

Randomized Clinical Trial to Evaluate The Effect of Metformin-GLP-1 Receptor Agonist Versus Oral Contraceptive (OC) Therapy on Reproductive Disorders and Cardiovascular Risks in Overweight Polycystic Ovarian Syndrome (PCOS) Patients

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Concentration of LH was measured in mIU/ml.

Weight and height will be combined to report BMI in kg/m\^2.

Alanine transaminase was measured in IU/L.

Systolic blood pressure was measured in mmHg.

Changes in testosterone levels were measured

Xinqiao Hospital of Chongqing

Deputy Chief Physician, Associated professor

Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks.

Metformin-GLP-1 Receptor Agonist: metformin oral with exenatide/liraglutide subcutaneous injection.

Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks.

Metformin-Oral Contraceptive(OC): metformin with Diane 35 oral intake.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

China

Region of Enrollment

weight

Limitations of this trial include a relatively small sample size and single-center design.

Min Long, MD

Assessment of Reproductive Functions

Basic Vital Signs

Assessment of Liver Function

Assessment of Blood Pressure

Assessment of Reproductive Function

Overall Study

IV administration of kisspeptin 112-121; 24-hour infusion. IV administration of GnRH; up to one bolus.

IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin

kisspeptin 112-121

GnRH

Study Coordinator

Stephanie B Seminara, MD

The goal of this study is to assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).

Assignment: All study subjects will undergo the same interventions. Baseline LH secretion patterns of individuals with PCOS will be compared to their LH secretion patterns while receiving a kisspeptin infusion.

Delivery of Interventions:

* Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories.
* On the day of the study, the subjects will have an intravenous (IV) line placed and

  * Undergo up to q10 min blood sampling x 36 hours
  * Receive an infusion of kisspeptin x 24 hours
  * Receive up to two kisspeptin IV boluses
  * Receive up to one gonadotropin-releasing hormone (GnRH) IV bolus

Dampening the Reproductive Axis With Continuous Kisspeptin

Average change in LH pulse frequency before and during kisspeptin infusion

Average change in LH pulse amplitude before and during kisspeptin infusion

Stephanie B. Seminara, MD

Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Hypogonadism

Hyperprolactinemia

Kallmann Syndrome

Pituitary Diseases

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Disorders of Sex Development

Disorder of Sex Development, 46,XY

Congenital Abnormalities

Urogenital Abnormalities

Male Urogenital Diseases

Genetic Diseases, Inborn

Galactorrhoea-Hyperprolactinaemia

Intravenous (IV) or subcutaneous (SC) administration of kisspeptin 112-121 and/or administration of GnRH

One or more IV or SC doses of kisspeptin 112-121, and/or short infusion (up to 12 hours) of kisspeptin 112-121

One or more IV doses of GnRH, and/or SC administration of GnRH

Yee-Ming Chan, MD, PhD

Margaret Lippincott, MD

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.

The reproductive hormone GnRH is essential for normal reproductive function. People with idiopathic hypogonadotropic hypogonadism (IHH), hyperprolactinemia, and polycystic ovarian syndrome (PCOS) do not secrete or respond to GnRH in a normal way. In this study, investigators will give participants kisspeptin-a hormone that is naturally found in the human body and is known to be a powerful stimulus of GnRH secretion. They may also give participants GnRH to determine if participants will be able to fully respond to kisspeptin. The goal of this study is to use kisspeptin administration to probe the condition of GnRH neurons in people with various reproductive disorders to better understand the underlying reasons for the disorders. Investigators hope to gain new insights into GnRH neuronal function (or dysfunction) that will lead to better diagnostics in the future.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS	NCT03151005	Polycystic Ovar... Overweight Obesity	Metformin-GLP-1... Metformin-Oral ...	18 Years - 50 Years	Xinqiao Hospital of Chongqing
The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS	NCT03151005	Polycystic Ovar... Overweight Obesity	Metformin-GLP-1... Metformin-Oral ...	18 Years - 50 Years	Xinqiao Hospital of Chongqing
Dampening the Reproductive Axis With Continuous Kisspeptin	NCT05971849	Reproductive Di... PCOS Polycystic Ovar...	kisspeptin 112-... GnRH	18 Years - 45 Years	Massachusetts General Hospital
Kisspeptin Administration in the Adult	NCT00914823	Hypogonadotropi... Kallmann Syndro... GnRH Deficiency PCOS Polycystic Ovar... Hyperprolactine...	kisspeptin 112-... GnRH	18 Years -	Massachusetts General Hospital
Dampening the Reproductive Axis With Continuous Kisspeptin	NCT05971849	Reproductive Di... PCOS Polycystic Ovar...	kisspeptin 112-... GnRH	18 Years - 45 Years	Massachusetts General Hospital

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