Polycystic Ovary Syndrome Clinical Trial
— PCOSMICOfficial title:
Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome
1. Metformin increases the pregnancy rate when added to the standard treatment of
anovulatory polycystic ovary syndrome (PCOS).
2. Metformin in combination with clomiphene, is more effective than clomiphene alone or
metformin alone improves fertility outcomes in women with PCOS of reasonably healthy
body weight (BMI </= 32).
3. Metformin improves fertility outcomes in women with BMI > 32 with PCOS.
Status | Completed |
Enrollment | 171 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility |
Inclusion Criteria: - Women between the age of 18 and 39 years inclusive. - Anovulatory infertility of duration at least 12 months. - Polycystic ovary syndrome, based on Rotterdam consensus criteria. - Normal serum prolactin, thyroid function and 17-hydroxyprogesterone. - Normal serum prolactin, thyroid function and 17-hydroxyprogesterone; Exclusion Criteria: - Presence of any other significant infertility factor including male factor, known tubal disease or history of an ectopic pregnancy, known endometriosis affecting the fallopian tubes or ovaries. - Already taking oral hypoglycaemics. - Diabetics receiving treatment. - Renal impairment - Chronic hepatic disease - Cardiac Disease - Alcohol dependency - Pre-disposition to lactic acidosis - Previous ovarian drilling procedure, gonadotrophin injection therapy, IUI (intrauterine insemination) or IVF ( in vitro fertilisation). - For those women who have had previous fertility treatment, the following would be excluded: - Women who have had > 5 cycles of clomiphene citrate - Women who have had > 5 months metformin treatment previously - Women who have proven to be resistant to 100mg or more of clomiphene citrate. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
New Zealand | University of Auckland | Auckland |
Lead Sponsor | Collaborator |
---|---|
University of Auckland, New Zealand | Auckland Medical Research Foundation, Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists |
New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical pregnancy | within 6 calendar months of randomisation | No | |
Secondary | Live birth | No | ||
Secondary | Adverse events | Yes |
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 | |
Completed |
NCT02098668 -
Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON
|
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 | |
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 |