Polycystic Ovary Syndrome, Infertility
Conditions
Keywords
Polycystic ovary syndrome, Progestin, Endometrial shedding, Ovulation induction cycles, Clomiphene citrate, Clinical pregnancy rate
Brief summary
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.
Interventions
DRUGProgestin
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.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* Polycystic ovary syndrome (Rotterdam 2003 Consensus Criteria) and a diagnosis of anovulatory infertility * Age 18-38 years * At least 1 patent fallopian tube (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year) * Normal semen analysis (total motile sperm count \>20million/ml) * Normal uterine cavity (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year) * Undergoing ovulation-induction with clomiphene citrate without intra-uterine insemination (IUI)
Exclusion criteria
* Body mass index (BMI) \< 17 kg/m2 or \> 40 kg/m2 * Prior treatment with clomiphene citrate * Presence of a hydrosalpinx (as seen on ultrasound, hysterosalpingogram, hydrotubation or hysterosonogram) * Those with systemic disease such as diabetes mellitus, uncontrolled thyroid disease, systemic lupus erythematosus and antiphospholipid antibody syndrome * Any other cause of infertility other than anovulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate per ovulation | 6 weeks after starting clomiphene | clinical pregnancy rate (gestational sac seen on ultrasound approximately 6-7 weeks after starting clomiphene) per ovulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ovulation rate | assessed 1 month after each induced ovulation cycle | ovulation rate (progesterone \>10nmol/L per clomiphene cycle) |
| ongoing pregnancy rate | assessed 12 weeks after clinical pregnancy is acheived | ongoing pregnancy rate (pregnancy with a fetal heartbeat \>12 weeks gestational age) |
| cumulative pregnancy rate | assessed 9 months after the ovulation induction cycles | cumulative pregnancy rate |
| multiple pregnancy rate | Assessed 4 months after clinical pregnancy acheived | multiple pregnancy rate (twins and higher order multiples) |
| endometrial thickness | Assessed at 1 month after conception | endometrial thickness (assessed via transvaginal ultrasound) |
| miscarriage rate | Assessed 4 months after clinical pregnancy acheived | miscarriage rate |
Countries
Canada
Outcome results
None listed