Polycystic ovary syndrome (PCOS)
Conditions
Interventions
Trade Name: Clomid, tabletten 50 mg
Product Name: Clomid, tabletten 50 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: CLOMIFENE CITRATE
CAS Number: 50-41-9
Other descriptive name: CLOMIFENE CITRA
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Rotterdam criteria for PCOS (cf. the recent ESHRE guidelines): at least 2 out of 3 criteria should be fulfilled: - irregular cycle (shorter than 21 days or longer than 35 days); - clinical (modified Ferriman-Gallwey score = 6) or biochemical signs (elevated free testosterone) of hyperandrogenism (www.eshre.eu/Guidelines-and-Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx); - PCO ovaries on ultrasound (www.eshre.eu/Guidelines-and-Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx): multiple small cysts (= 20 per ovary and/or an ovarion volume = 10 ml, measured with a probe >8 MHz) in both ovaries. Age: 18 until 40 years old (extremes included). A first treatment cycle, possibly combined with intra uterine insemination (IUI) and this for (one of) the following reasons: - mild male factor (as defined by each local center) - endometriosis AFS score 1 or 2 Use of own or donor sperm. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 320 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Tubal factors - Uterine factors - Endometriosis AFS score 3 or 4 - Moderate to severe male factor (as defined by each local center) - BMI > 35
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study if the pregnancy rates (COPR: cumulative ongoing pregnancy rate) after 3 treatment cycles with inositol are comparable to 3 cycles of ovulation induction with clomiphene citrate.;Secondary Objective: To investigate whether the compliance for the patient is acceptable. Therefore, potential adverse events (e.g. ovarian hyperstimulation syndrome), the occurrence of ovulation, cancelling of treatment cycles, and multiple pregnancies are registered. ;Primary end point(s): Pregnancy rates (COPR: cumulative ongoing pregnancy rate);Timepoint(s) of evaluation of this end point: After 3 treatment cycles of inositol (study group) or 3 ovulation induction cycles with clomiphene citrate (control group) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Live birth rate number of gestational sacs number of cancelled treatment cycles and persistent anovulation;Timepoint(s) of evaluation of this end point: 32-42 weeks after conception at the time of the first ultrasound (around 7 weeks) during the study | — |
Countries
Belgium
Contacts
Public ContactHIRUZ
Ghent University Hospital
Outcome results
None listed