Polycystic Ovary Syndrome Clinical Trial
Official title:
A Randomized Double-blind Controlled Trial on the Effect of Vitamin D on Ovulation Rate of Women With Polycystic Ovary Syndrome
Verified date | May 2024 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized double-blind controlled trial on the effect of vitamin D supplementation to assess the ovulation rate of women with polycystic ovary syndrome (PCOS) and other reproductive, endocrine and metabolic outcomes after one year of treatment.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Premenopausal - Aged 18-40 years - Irregular long menstrual cycles (>35 days) - PCOS according to the Rotterdam criteria - Agree for transvaginal ultrasound Exclusion Criteria: - Use of hormonal medication (including contraception) within 3 months prior to study inclusion, except the use of a progestogen to induce withdrawal bleeding every 3 months - History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/ or hypercalcemia, including active tuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ ureteral stones, parathyroid disease, renal or liver failure or current use of anti-convulsants - Use of insulin-sensitizing drugs, lipid lowering drugs or anti-hypertensive - Anticipated to use the above medications in the coming one year - Known type 2 diabetes mellitus - Refusal to join the study - Abnormal blood calcium level For those on supplements, we asked them to stop their own supplements. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Kwong Wah Hospital | Hong Kong | |
Hong Kong | Princess Margaret Hospital | Hong Kong | |
Hong Kong | Queen Mary Hospital, University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Kwong Wah Hospital, Pamela Youde Nethersole Eastern Hospital, Princess Margaret Hospital, Hong Kong, The Queen Elizabeth Hospital |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ovulation rate | Serum progesterone | 12 months | |
Secondary | Change in serum 25(OH)D level | Serum 25(OH)D | 12 months | |
Secondary | Pregnancy rate | Positive urine or serum hCG test | 12 months | |
Secondary | Live birth rate | Delivery of a baby after 22 completed weeks of gestational age, or with birth weight of 500 grams if the gestation age is unknown, which shows evidence of life | 12 months | |
Secondary | Change in serum anti-Mullerian hormone level | serum AMH level | 12 months | |
Secondary | Change in antral follicle count | Antral follicle count measured by transvaginal/ transrectal ultrasound | 12 months | |
Secondary | Androgen indices | serum androgen and androstenedione levels, SHBG | 12 months | |
Secondary | Body mass index | Height in cm, weight in kg, to calculate the body mass index (kg/m^2) | 12 months | |
Secondary | Change in waist and hip circumference | waist and hip circumference in cm | 12 months | |
Secondary | Rate of diabetes mellitus/ impaired glucose intolerance | Measured by fasting and 2 hour glucose (post 75g OGTT) | 12 months | |
Secondary | Change in systolic and diastolic blood pressure | Blood pressure | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03142633 -
MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
|
||
Completed |
NCT06158932 -
A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Active, not recruiting |
NCT02500147 -
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
|
Phase 4 | |
Completed |
NCT04932070 -
Berberine and Polycystic Ovary Syndrome
|
N/A | |
Suspended |
NCT03652987 -
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
Completed |
NCT03480022 -
Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS
|
Phase 3 | |
Active, not recruiting |
NCT03043924 -
Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)
|
N/A | |
Completed |
NCT05246306 -
Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
|
||
Completed |
NCT05981742 -
Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS
|
Phase 2 | |
Completed |
NCT05702957 -
Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome
|
Phase 2/Phase 3 | |
Completed |
NCT05029492 -
Effect of Visceral Manipulation on PCOS
|
N/A | |
Not yet recruiting |
NCT02255578 -
Endobarrier Treatment in Women With PCOS
|
Phase 3 | |
Completed |
NCT02924025 -
Motivational Interviewing as an Intervention for PCOS
|
N/A | |
Withdrawn |
NCT01638988 -
Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin
|
Phase 3 | |
Completed |
NCT02098668 -
Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON
|
N/A | |
Not yet recruiting |
NCT00883259 -
Metformin and Gestational Diabetes in High-risk Patients: a RCTs
|
Phase 4 | |
Completed |
NCT01462864 -
Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome
|
N/A | |
Recruiting |
NCT01431352 -
Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
|
N/A | |
Completed |
NCT00989781 -
Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome
|
N/A |