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

Thyroid Neoplasms

Thyroid Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Micronutrients

Anti-Infective Agents

Iodine

Cadexomer iodine

80-200 mCi of radioactive iodine will be given to thyroid cancer patients

radioactive iodine

Thyroid carcinoma is the most common endocrine malignancy. Surgery is the standard therapeutic approach for patients with differentiated thyroid carcinoma (DTC), followed by radioiodine (RAI) therapy if indicated. For women with DTC, the effects of RAI therapy on gonadal and reproductive function are an important consideration. This study aimed to evaluate the effects of RAI therapy on ovarian function.

Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer

Level of anti-Müllerian (AMH) hormone in female patients before and after radioactive iodine therapy.

Assiut University

Lecturer of nuclear medicine

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Breast cancer patients who will undergo chemotherapy

Breast cancer patients who will not undergo chemotherapy

More than two million American women are breast cancer survivors. Approximately one-third of these women are premenopausal at diagnosis and face issues related to reproduction as they undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian function in breast cancer survivors could significantly impact physicians and patients in counseling, medical and surgical treatment choices, and consideration of fertility preservation options.

The goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian imaging markers that can predict ovarian failure and characterize the course of ovarian function after chemotherapy. The investigators plan to follow a group of young women from breast cancer diagnosis to five years after chemotherapy. The investigators will study the following risk factors: blood hormone levels that reflect ovarian function, genetic mutations that affect how individuals metabolize chemotherapy, and ovarian size and egg count by MRI and ultrasound. The investigators hypothesize that these biomarkers are related to risk of ovarian insufficiency singly. After examining these individual risk factors for ovarian failure, the investigators will put them together into an Ovarian Failure Clinical Predictive Index. This index will be a tool similar to the Gail Model that can be used to determine individual risk for ovarian failure. This tool would assist young breast cancer patients and their physicians in making treatment decisions that would impact cancer survival and reproduction.

Predictors of Ovarian Insufficiency in Young Breast Cancer Patients

Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study)

Number of participant without of menses for 12 months after breast cancer diagnosis

Number of participants who experience return of menses after 3 months of amenorrhea

University of Pennsylvania

University of Southern California

American Cancer Society, Inc.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

University of California, San Diego

Professor of Obstetrics, Gynecology, and Reproductive Sciences

Exposed/Chemotherapy

Unexposed

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Irene Su, MD MSCE

25 participants could not be evaluated for this outcome due to censoring for cancer recurrence, death, bilateral salpingo-oophorectomy, or hysterectomy.

38 additional participants could not be evaluated for this outcome due to loss to follow up.

Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis

We did not undertake this analysis for participants who did not undergo chemotherapy (unexposed) or were censored for recurrence, death, hysterectomy or bilateral salpingo-oophorectomy (n=108) as this measure is not applicable

Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea

Overall Study

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
Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer	NCT04396158	Ovarian Insuffi... Radiation Expos...	radioactive iod...	15 Years - 45 Years	Assiut University
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
Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer	NCT04396158	Ovarian Insuffi... Radiation Expos...	radioactive iod...	15 Years - 45 Years	Assiut University
Predictors of Ovarian Insufficiency in Young Breast Cancer Patients	NCT01197456	Breast Cancer Ovarian Insuffi... Ovarian Failure		18 Years - 45 Years	University of California, San Diego

Spots Global Cancer Trial Database for ovarian insufficiency