Women with polycystic ovary syndrome (PCOS) can suffer from infertility because they do not produce an egg each month, resulting in irregular periods. As a result, these women often need a medication called clomiphene citrate (clomiphene) to induce ovulation. A traditional 'clomiphene protocol' begins with a short course of progestin treatment to bring on a period (termed a 'withdrawal bleed') before starting the clomiphene medication. Newer evidence, however, has suggested that this progestin-induced shedding of the uterine lining (i.e., withdrawal bleed) may decrease the chances of pregnancy. The purpose of our study is to determine whether withdrawal bleeding has an impact on pregnancy rates for patients with PCOS undergoing a clomiphene cycle. It is hypothesized that patients who undergo ovulation induction with clomiphene citrate without prior endometrial shedding will have higher clinical pregnancy rates than those who begin with a progestin-induced withdrawal bleed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The experimental group will have no progestin prior to ovulation induction with clomiphene citrate, while the comparison group will have progestin medication prior to ovulation induction with clomiphene citrate, as per usual care.
Pacific Centre for Reproductive Medicine
Burnaby, British Columbia, Canada
Clinical pregnancy rate per ovulation
clinical pregnancy rate (gestational sac seen on ultrasound approximately 6-7 weeks after starting clomiphene) per ovulation
Time frame: 6 weeks after starting clomiphene
cumulative pregnancy rate
cumulative pregnancy rate
Time frame: assessed 9 months after the ovulation induction cycles
ovulation rate
ovulation rate (progesterone \>10nmol/L per clomiphene cycle)
Time frame: assessed 1 month after each induced ovulation cycle
ongoing pregnancy rate
ongoing pregnancy rate (pregnancy with a fetal heartbeat \>12 weeks gestational age)
Time frame: assessed 12 weeks after clinical pregnancy is acheived
miscarriage rate
miscarriage rate
Time frame: Assessed 4 months after clinical pregnancy acheived
multiple pregnancy rate
multiple pregnancy rate (twins and higher order multiples)
Time frame: Assessed 4 months after clinical pregnancy acheived
endometrial thickness
endometrial thickness (assessed via transvaginal ultrasound)
Time frame: Assessed at 1 month after conception
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