Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Gland and Hormone Related Diseases

Nervous System Diseases

Rare Diseases

Hemorrhage

Syndrome

Infertility

Polycystic Ovary Syndrome

Uterine Hemorrhage

Hyperprolactinemia

Anovulation

Genital Diseases

Urogenital Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Uterine Diseases

Pituitary Diseases

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Galactorrhoea-Hyperprolactinaemia

Anticoagulants

All Drugs and Chemicals

Reproductive Control Agents

Bone Density Conservation Agents

Other Dietary Supplements

Citric Acid

Sodium Citrate

Progesterone

Clomiphene

Enclomiphene

Zuclomiphene

Calcium

Calcium, Dietary

Chelating Agents

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Citrate

Intervention, dosage and frequency: drug: Bushen Culuan Decoction 13g tid and Clomiphene Citrate Tablets placebo 50mg qd; Dosage form: Bushen Culuan Decoction is dissolved medicine and Clomiphene Citrate Tablets placebo is tablets; Duration: the medicine will be taken from 5th day of a menstrual cycle, Bushen Culuan Decoction is taken for 14 days while Clomiphene Citrate Tablets placebo being taken for 5 days. Then patients stop taking the medicine until the 5th day of next menstrual cycle. If the patient doesn't have a regular menstrual cycle, the medicine will be taken from 5th day from vaginal bleeding caused by taking progesterone. Each treatment cycle contains 3 menstrual cycle. If the patient regains normal ovulation at the end of the first treatment cycle, she will reach the end of the whole treatment, and if not she will start the second treatment cycle. All treatment will be terminated after 2 treatment cycles.

Intervention, dosage and frequency: drug: Clomiphene Citrate Tablets 50mg qd and Bushen Culuan Decoction placebo 13g tid; Dosage form: Clomiphene Citrate Tablets is tablet and Bushen Culuan Decoction placebo is dissolved medicine; Duration: the medicine will be taken from 5th day of a menstrual cycle, Clomiphene is taken for 5 days while Bushen Culuan Decoction placebo being taken for 14 days while. Then patients stop taking the medicine until the 5th day of next menstrual cycle. If the patient doesn't have a regular menstrual cycle, the medicine will be taken from 5th day from vaginal bleeding caused by taking progesterone. Each treatment cycle contains 3 menstrual cycle. If the patient regains normal ovulation at the end of the first treatment cycle, she will reach the end of the whole treatment, and if not she will start the second treatment cycle. All treatment will be terminated after 2 treatment cycles.

the same as group description including dosage, frequency and duration

experimental group: Bushen Culuan Decoction and Clomiphene Citrate Tablets placebo

control group: Clomiphene Citrate Tablets and Bushen Culuan Decoction placebo

Kun Ma, Dr.

Yuan Yuan, Master

This study is to evaluate the effectiveness and safety of Bushen Culuan Decoction in the treatment of anovulatory infertility, including anovulatory abnormal uterine bleeding, polycystic ovarian syndrome, hyperprolactinemia, luteinized unruptured follicle syndrome, corpus luteum insufficiency and ovarian insufficiency, through a randomised, double-blinded, double-dummy, parallel positive controlled, adaptive multicenter clinical trial.

Anovulation is one of the main causes of female infertility. Anovulatory infertility account for a proportion of 25-30% in whole female infertility.

In western medicine, hormone induced ovulation and assisted reproduction technology are two main ways to solve the problem and Clomiphene citrate is the first-line medication in ovulation induction. There are many side effects being reported in the treatment with modern medicine technique such as ovarian hyperstimulation syndrome, complication with uteroscope and puncture egg retrieval, low pregnancy rate with high ovulation rate, potential cancer occuring risk and offspring healthy risk.

Bushen Culuan Decoction is a traditional Chinese medicine recipe with 10 Chinese herbs including Tusizi, Yinyanghuo, Xianmao, Xuduan, Gouqizi, Nvzhenzi, Zelan, Shengpuhuang, Xiangfu and Chuanshanlong. Previous laboratory and exploratory clinical researches have proved Bushen Culuan Decoction had an exactly efficacy in treating anovulatory infertility safely.

In the first stage, the primary sample size In the study is 528. Half patients will receive Bushen Culuan Decoction and clomiphene citrate placebo, while the other half will receive clomiphene citrate tablets and Bushen Culuan Decoction placebo. When 1/3 of 528 patients complete the treatment, we will analysis the treatment efficacy of 6 diseases separately, and find which of them could be the target diseases of Bushen Culuan Decoction. Then we will modify the sample size depending on the result in first stage, and the research will only be processed in the target diseases being chosen. In the next stage, half patients will receive Bushen Culuan Decoction and clomiphene citrate placebo, while the other half will receive clomiphene citrate tablets and Bushen Culuan Decoction placebo.

Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility

Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility：A Clinical Research of "Same Treatment for Different Diseases"

If the patient participate 1 treatment cycle, the ovulation will be measured 3 menstrual cycles, and if the patient participate 2 treatment cycle, the ovulation will be measured 6 menstrual cycles.

Including Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Prolactin (PRL), Estradiol (E2), Progesterone(P), Testosterone (T).

The type of endometrium is measured by ultrasound. The type of endometrium contains type A, B, and C. Type A means the endometrium thickness is about 4-9mm, and there is a "trilaminar patterns" in the image. Type B means the endometrium thickness is about 9-12mm, the image shows moderate homogeneous echo. Type C means the endometrium thickness is about 10-14mm with a strong homogeneous echo. The type only represents different forms of endometrium, but not represents endometrium level or grade.

Pulsatility Index (PI) of Uterus and Bilateral Ovaries is the pulsatility index of uterine arteries and bilateral ovarial arteries. The normal range of uterine PI has no unified standard, but the smaller the index is, the better the endometrial receptivity is. Generally, when uterine PI\<2, the endometrial receptivity will be good enough to get zygote implantation, and when uterine PI\>3, the endometrial receptivity is too improper to get zygote implantation.

Resistant Index (RI) of Uterus and Bilateral Ovaries is the resistant index of uterine arteries and bilateral ovarial arteries. The normal range of uterine RI has no unified standard, but the smaller the index is, the better the endometrial receptivity is.

Including prothrombin time, activated partial thromboplastin time, fibrinogen and thrombin time

Traditional Chinese Medicine Symptom Score (point) including:

amenorrhea (0-3); delayed menstruation (0-3); scant menstruation (0-3); weakness in lower back, waist and knees (0-3); dizziness and tinnitus (0-3); sexual apathy (0-3); fatigue (0-3); colorless transparent urination(0-3); frequent urination at night (0-3); feeling obstruction with menstruation (0-3); profuse menstruation with dark color (0-3); clot in menstruation (0-3); stabbing pain in lower abdomen area, may aggravating with sexual intercourse (0-3); dysmenorrhea (0-3) The total score will be measured by summing the subitems' score above, and the total score range is 0-42. The higher the score is, the worse the situation is.

Dongzhimen Hospital, Beijing

Beijing Obstetrics and Gynecology Hospital

Beijing Hospital of Traditional Chinese Medicine

Beijing First Hospital of integrated Chinese and Western Medicine

Beijing Fengtai Hospital of Integrated Traditional and Western Medicine

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Endometriosis

healthy women PCOS Endometriosis hyperprolactinemia fertility treatment

Fertility treatment

Brigitte Leeners, MD

Development of a bio-mathematical model of the human female cycle

From hormonal measurements throughout 1-2 menstrual cycles in women with and without endocrinological pathology a mathematical model of the human menstrual cycle will be generated. The model will serve to predict development of the cycle including ovulation as well as to better understand the pathophysiology of endocrinological disorder. In a second step current treatment protocols for fertility treatment will be integrated into the model in order to optimize treatment outcome.

Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON

Model Driven Computation for Infertility Related Endocrinological Diseases - PAEON

To better understand the pathophysiological mechanisms in endocrinological diseases

Development of a mathematical model of the menstrual cycle

Mathematical model to improve fertility treatments

University of Zurich

Nutritional and Metabolic Diseases

Hyperlipoproteinemias

Hyperlipidemias

Insulin Resistance

Prolactinoma

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Dyslipidemias

Lipid Metabolism Disorders

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pituitary Neoplasms

Endocrine Gland Neoplasms

Hypoglycemic Agents

Cardiotonic Agents

Insulin

Insulin, Globin Zinc

Dopamine

Dopamine Agonists

Erika CO Naliato, MSc

Prolactin is suggested to influence insulin resistance, but scarce data is available on the metabolic profile of patients with prolactinoma.

The purpose of the protocol was to evaluate cardiovascular disease risk factors in women with prolactinoma treated with dopamine agonists and to study the influence of disease control and anthropometry on their metabolic profile.

A cross-sectional study was performed in non-obese premenopausal women with prolactinoma treated with dopamine agonists evaluated regarding glucose, insulin, Homeostasis Model Assessment (HOMA), lipid profile, C reactive protein (CRP), body mass index (BMI), waist circumference, prolactin, estradiol, testosterone, and sex hormone binding globulin (SHBG). They were compared with control women of similar age and BMI distribution.

Insulin Resistance in Women With Prolactinoma

Insulin Resistance and Lipid Profile in Non-Obese Women With Prolactinoma Treated With Dopamine Agonists

Universidade Federal do Rio de Janeiro

Obesity

Who were diagnosed with prolactin levels above the upper limit of normal (24.29 ng/ml) and under 100 ng/ml.

Without PCOS and with normal prolactin levels.

Ming-I Hsu, MD

Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder of reproductive-age women. According to Rotterdam 2003 criteria: at least two of three criteria are met, hyperandrogenism, chronic anovulation, and polycystic ovary. PCOS will cause irregular menstrual cycle, infertility, acne, hirsutism, obesity, or/and metabolic syndrome, diabetes that may increase risk of cardiovascular disease.

Hyperprolactinaemia is also a common problem in reproductive aged women. Both hyperprolactinaemia and PCOS had endocrine disorder and irregular menstrual cycle. Investigators hope to collect clinical data from PCOS and prolactinemia patients followed in Wang Fang hospital for many years in endocrinological and metabolical aspects for comparison. Investigators at the same time would like to understand more about other similarities and differences between these two endocrinological dysfunction for future study.

The Relationship of PRL and Polycystic Ovary Syndrome (PCOS) in Taiwan's Women

Relationship of Metabolic Parameters, Endocrine and Prolactin Levels in Taiwan's Women With Polycystic Ovary Syndrome and Hyperprolactinemia.

Taipei Medical University WanFang Hospital

Attending Doctor

Diseases and Abnormalities at or Before Birth

Hypogonadism

Kallmann Syndrome

Disorders of Sex Development

Disorder of Sex Development, 46,XY

Congenital Abnormalities

Urogenital Abnormalities

Male Urogenital Diseases

Genetic Diseases, Inborn

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

kisspeptin 112-121

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

GnRH

Study Coordinator

Stephanie B Seminara, MD

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.

Kisspeptin Administration in the Adult

Administration of Kisspeptin to Subjects With Reproductive Disorders

Massachusetts General Hospital

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility	NCT03709849	Anovulatory Inf... Abnormal Uterin... Polycystic Ovar... Hyperprolactine... Luteinized Unru... Corpus Luteum I... Ovarian Insuffi...	experimental gr... control group: ...	21 Years - 40 Years	Xiyuan Hospital of China Academy of Chinese Medical Sciences
Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON	NCT02098668	Polycystic Ovar... Endometriosis Hyperprolactine...	Fertility treat...	18 Months - 43 Years	University of Zurich
Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility	NCT03709849	Anovulatory Inf... Abnormal Uterin... Polycystic Ovar... Hyperprolactine... Luteinized Unru... Corpus Luteum I... Ovarian Insuffi...	experimental gr... control group: ...	21 Years - 40 Years	Xiyuan Hospital of China Academy of Chinese Medical Sciences
Insulin Resistance in Women With Prolactinoma	NCT00481299	Prolactinoma Insulin Resista... Hyperlipidemia		18 Years - 48 Years	Universidade Federal do Rio de Janeiro
The Relationship of PRL and Polycystic Ovary Syndrome (PCOS) in Taiwan's Women	NCT01117272	Polycystic Ovar...		15 Years - 45 Years	Taipei Medical University WanFang Hospital
Kisspeptin Administration in the Adult	NCT00914823	Hypogonadotropi... Kallmann Syndro... GnRH Deficiency PCOS Polycystic Ovar... Hyperprolactine...	kisspeptin 112-... GnRH	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for hyperprolactinemia