Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Gland and Hormone Related Diseases

Syndrome

Infertility

Polycystic Ovary Syndrome

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

May Health Procedure performed with use of the May Health Kit intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.

The intervention consists in the realisation of the May Health Procedure using the May Health Kit, which comprises two elements: a disposable device (May Health Device) and a radiofrequency (RF) energy generator (May Health System). The May Health Device is a short-term invasive device delivered and positioned through the vagina to deliver RF energy inside the ovary in order to ablate ovarian tissue.

May Health Kit

Saad Amer, MD, PhD

The objective of this study is to provide preliminary evidence for the safety and effectiveness of the May Health Kit in transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.

A Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With PCOS Infertility

ULTRA Study: a Feasibility, Prospective, Multicenter, Single-arm Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualisation in Women With Polycystic Ovary Syndrome (PCOS)

May Health

Nervous System Diseases

Rare Diseases

Hemorrhage

Uterine Hemorrhage

Hyperprolactinemia

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

Hypoglycemic Agents

Micronutrients

Vitamins

Mineral

Metformin

Vitamin D

Cholecalciferol

Trace Elements

Vitamin D3

Calciferol

Calcium Supplement

Experimental Group (Group A; n=71):

The intervention (experimental) group will receive VD injections 600,000 I.U I/M once with 1 gram calcium supplemental daily in the initial 12 weeks. After that standard PCOS care; i) Glucophage XR 750 mg (once for 15 days then twice daily) ii) progesterone supplementation (1 capsule Progeffik 100 mg every 3 weeks, then 1 week off) and iii) calcium supplements will be given for next 12 weeks.

Control Group (Group B; n=71):

Participants will receive standard PCOS treatment; Glucophage XR 750 mg once at dinner for 15 days then twice daily and Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off for initial-- 12 weeks.

Then VD supplementation (600,000 IUI/M) will be given once during the study period with Calcium 1000 mg/day and continued Standard PCOS treatment from 12- 24 weeks

Intervention Group Initial 12 weeks;

* VD supplementation (600,000 IU I/M) once during the study period
* Elemental calcium 1000 mg/day From 12-24 weeks: Standard PCOS;
* Glucophage XR 750 mg once at dinner for 15 days then twice daily
* Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off
* Calcium 1000 mg/day

Active Comparator (Group B; n=71):

Initial-- 12 weeks;

* Standard PCOS;
* Glucophage XR 750 mg once at dinner for 15 days then twice daily
* Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off From 12- 24 weeks
* VD supplementation (600,000 IUI/M) once during the study period
* Calcium 1000 mg/day
* Standard PCOS Continued

Active Comparator

Rehana Rehman, PhD

Poly cystic Ovarian Syndrome (PCOS) is an endocrine disorder of reproductive age defined by "the presence of any two out of three criteria: oligo and/or anovulation, excess androgen activity and/or polycystic ovarian morphology on ultrasound". Considering role of vitamin D (VD) (3, 4) and high prevalence (58%) of deficiency in PCOS of Pakistan. Researchers hypothesized that its correction would improve response to standard PCOS treatment. The objective is to compare PCOS parameters in intervention group (Group A) receiving VD supplementation and then PCOS care with control group (Group B) receiving standard PCOS care and then VD supplementation. A randomized open label trial: delayed-start design will be conducted on VD deficient PCOS females VD \< 20ng/ml ; Group A will receive VD injections 600,000 I.U I/M once with 1 gram calcium supplement daily in the initial 12 weeks. After that standard PCOS care; i) Glucophage XR 750 mg (once for 15 days then twice daily) ii) progesterone supplementation (1 capsule Progeffik 100 mg every 3 weeks, then 1 week off) and iii) calcium supplements will be given for next 12 weeks. PCOS females in Group B will receive standard PCOS care (same) with addition of VD and calcium supplementation after 12 weeks till study end point. Study outcomes will be comparison of i) hyperandrogenism by Free Androgen Index \[Total Testosterone, Steroid Hormone Binding Globulin ii) insulin Resistance by HOMA-IR (serum Insulin, Fasting Blood Glucose) and iii) oxidative stress by Total Antioxidant Capacity after 24-weeks in these Groups'd levels after supplementation will be assessed for confirmation of correction and calcium and albumin levels for detection of hypercalcemia. Results of this study will inform the clinicians to add VD before or after the standard PCOS care for rectification of endocrine and metabolic derangements as a cost-effective treatment and prevention strategy in these females.

This study will comprise of two groups (A and B) with 71 participants in each group carried for a duration of 24 weeks.

Intervention Details for Group A (Duration 1-12 weeks):

Participants will be given Vitamin D (VD) supplementation at a dose of 600,000 IU along with Calcium 1000 mg/day.

Mid-Point (At 12 weeks):

Patients will have a consultation for clinical interpretation. They will undergo biochemical assessment, including the estimation of Insulin Resistance, Free Androgen Index, and Total Antioxidant Capacity.

After 12 weeks They will receive standard treatment for Polycystic Ovary Syndrome (PCOS), which includes Glucophage XR 750 mg once at dinner for 15 days, then twice daily. Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off and Calcium 1000 mg/day

Intervention Details for Group B (Duration 1-12 weeks):

Participants in Group B will receive standard PCOS treatment mentioned earlier:

Glucophage XR 750 mg once at dinner for 15 days, then twice daily. Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off. Additionally, they receive Calcium 1000 mg/day.

Mid-Point (At 12 weeks):

Patients will have a consultation for clinical interpretation. They will undergo biochemical assessment, including the estimation of Insulin Resistance, Free Androgen Index, and Total Antioxidant Capacity.

Intervention Details for Group A (After 12 weeks)

They will receive VD supplementation (600,000 IU) during this time and continue to receive Calcium 1000 mg/day.

Calculations of HOMA-IR and Free Androgen Index will be done at 12 and 24 weeks and the results will be compared.

{HOMA-IR: HOMA- IR index, a commonly used marker of IR, will be calculated using the formula: HOMA-IR = fasting glucose levels \[mmol/L\] × fasting insulin levels \[μU/mL\]/22.5 Free Androgen Index will be derived from TT and SHBG, normally measured in nanomoles per liter. FAI =100 (TT /SHBG)}

Infertile females with Polycystic Ovarian Syndrome

Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome

Efficacy of Vitamin D Supplementation in Females With Polycystic Ovary Syndrome: a Randomized Open Label Delayed-start Design

hyperandrogenism by Free Androgen Index \[Total Testosterone, Steroid Hormone Binding Globulin

HOMA-IR (serum Insulin, Fasting Blood Glucose)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With PCOS Infertility	NCT03760926	Polycystic Ovar...	May Health Kit	18 Years - 40 Years	May Health
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
A Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With PCOS Infertility	NCT03760926	Polycystic Ovar...	May Health Kit	18 Years - 40 Years	May Health
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome	NCT06045351	Anovulatory Inf...	Vitamin D Active Comparat...	18 Years - 45 Years	Aga Khan 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

Spots Global Cancer Trial Database for anovulatory infertility