Clomiphene (aka clomid) is very often used to induce ovulation in women with polycystic ovary syndrome. If ovulation does not occur at a dose of 50 mg, then withdrawal bleeding is caused by prescribing progestin, and the dose of clomiphene increases in the next cycle.
With a newer step-by-step protocol, the dose of clomiphene increases without causing withdrawal bleeding.
The presented study, which took place in the USA, involved 109 patients with polycystic ovary syndrome. The patients were divided into 2 groups:
- the first group of 66 patients received clomiphene according to the traditional scheme: initially, a dose of 50 mg was used for 5 days, if there was no response with a documented progesterone level of less than 3 ng/ml on the 21st day of the cycle, then medroxyprogesterone acetate 10 mg was prescribed for 10 days to cause withdrawal bleeding. After that, the dose of clomiphene was increased to 100 mg / day for 5 days. This continued until the maximum dose of clomiphene was 250 mg/day.
- the second group of 43 patients received clomiphene according to a stepwise protocol: initially a dose of 50 mg was used for 5 days, then 5-7 days after the last dose of clomiphene, ultrasound was performed to assess the follicular response. If no developing follicle > 10 mm was detected, the dose was increased to 100 mg/day for 5 days. Then, 5-7 days after the last dose of clomiphene, ultrasound was performed to assess the follicular response and if no developing follicle > 10 mm was detected, the dose was increased in the same manner, increasing the dose by 50 mg / day in each step, bringing it to a maximum dose of 250 mg / day.
The primary outcome was considered to be the time before ovulation. Secondary outcomes were considered to be the frequency of ovulation, the frequency of pregnancy, side effects depending on the dose of the drug.
According to the results of the study:
- the time before ovulation was shorter with the step protocol: 23 days with the step protocol and 48 days with the traditional scheme.
- cumulative ovulation frequency was higher in the group with the step protocol: 88% versus 39% with the traditional scheme.
- the frequency of pregnancy was the same in both groups: 18 % vs. 16 %.
- in the group with the step protocol, mild side effects were more often noted: vasomotor hot flashes, headache, nausea, mastalgia and mood changes.
- there was no difference in the frequency of serious side effects.
The authors note that for women with polycystic ovary syndrome, the use of clomiphene according to a step-by-step protocol is associated with a reduction in the time to ovulation and an increased frequency of ovulation compared with the traditional regimen of the drug.