Ovulation Induction / PCOS

Traditional Clomiphene Citrate Administration Versus a Stair-Step Approach: A Randomized Controlled Trial:

This research study is an investigator initiated trial in which you will be randomized to either the traditional protocol of clomiphene citrate or the stair-step protocol.  Randomization means that you are put in a group by chance, like the flip of a coin.  It was designed to compare length of time to ovulation and pregnancy with escalating doses of clomiphene citrate administration in the traditional protocol versus the stair-step approach in women with ovulatory dysfunction.

The traditional administration of clomiphene citrate for ovulation induction involves taking clomiphene citrate for 5 days.  If ovulation does not occur within 14 days, a progestin pill (such as Provera) is prescribed for 10 days to induce a period (which normally occurs within 1 week of stopping the pill).  Then a higher dose of clomiphene citrate will be prescribed. 

The stair-step administration of clomiphene citrate for ovulation induction also involves taking clomiphene citrate for 5 days.  In contrast, if ovulation does not occur within 7-9 days, a progestin pill (such as Provera) would NOT be taken to induce a period.  The dose of clomiphene will then be increased.  Therefore, this would do away with the 10 days of taking the progestin pill, and also do away with waiting for a period (usually 3 to 7 days) for a total of up to a 20 day difference between clomiphene citrate dosing cycles. 

Participants will be women ages 18 to 45 who have been diagnosed with ovulatory dysfunction. Patients must have undergone six months of unprotected intercourse without pregnancy. Study duration will be up to 6 cycles which could take up to 6-12 months.

Clomiphene citrate will be provided to you at no cost.  All other medications, ultrasounds, and blood draws that would normally be part of the ovulation induction process, will be the responsibility of you or your insurance company.

Principal Investigator:    LaTasha Craig, MD

Co Investigator:             Karl Hansen, MD, PhD

Funding Source:            OU Physicians Reproductive Medicine

IRB Number:                14852