Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged).
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.
University Hospital
Ghent, Belgium
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.
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.
Time frame: At 7 - 8 gestational weeks
The number of potential adverse events
The potential adverse events will be measured to determine whether the compliance for the patient is acceptable.
Time frame: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
The occurrence of ovulation
The occurence of ovulation will be measured to determine whether the compliance for the patient is acceptable.
Time frame: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
The number of cancelled treatment cycles
The number of cancelled treatment cycles will be measured to determine whether the compliance for the patient is acceptable.
Time frame: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
The number of multiple pregnancies
The number of multiple pregnancies will be measured to determine whether the compliance for the patient is acceptable.
Time frame: During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.