Clomiphene, Inositol, Ovulation Induction, Polycystic Ovary Syndrome
Conditions
Brief summary
Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.
Interventions
DRUGMyo-inositol
2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged).
DRUGClomiphene Citrate
Each tablet contains 50 mg of clomiphene citrate which means 33,9 mg of clomiphene. Other constituents are sucrose, lactose monohydrate, corn starch, pregelatinized starch, yellow iron oxide (E172) and magnesium stearate (E470b). Dosing: 1 tablet per day from cycle day 3 until 7 (extremes included), stepping up until a maximum dose of 3 tablets per day for 5 consecutive days.
Sponsors
Gedeon Richter Plc.
University Hospital, Antwerp
AZ Jan Palfijn Gent
Our Lady of Lourdes Hospital Waregem
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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 ovarian volume ≥ 10 ml, measured with a probe \>8 MHz) in both ovaries. * 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.
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 | Description |
|---|---|---|
| Rate of cumulative ongoing pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after 3 treatment cycles with inositol versus clomiphene citrate for ovulation induction. | At 7 - 8 gestational weeks | Recently, a meta-analysis on the use of inositol in PCOS was published. This study showed that inositol leads to a more regular menstrual cycle and recovery of ovarian function. Less data are present on pregnancy rates. No RCT was found on the comparison between inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate. Another advantage of inositol is that it doesn't have side effects compared to metformin and that there is no elevated risk on multiple pregnancies, which is the case with clomiphene citrate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of potential adverse events | During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks) | The potential adverse events will be measured to determine whether the compliance for the patient is acceptable. |
| The occurrence of ovulation | During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks) | The occurence of ovulation will be measured to determine whether the compliance for the patient is acceptable. |
| The number of cancelled treatment cycles | During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks) | The number of cancelled treatment cycles will be measured to determine whether the compliance for the patient is acceptable. |
| The number of multiple pregnancies | During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks) | The number of multiple pregnancies will be measured to determine whether the compliance for the patient is acceptable. |
Countries
Belgium
Outcome results
None listed