Clinical Trial: Traditional Clomiphene Citrate Administration vs. Stair-step Approach
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Traditional Clomiphene Citrate Administration Versus a Stair-Step Approach: A Randomized Controlled Trial
Brief Summary:
The purpose of this study is to compare the length of time to achieve ovulation and pregnancy with a traditional protocol administration of clomiphene citrate versus a stair step administration.
Our hypothesis is by using a stair-step approach in which a period is not induced between administrations of escalating doses of clomiphene citrate, the time to ovulation and pregnancy may be reduced.
Detailed Summary:
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.
Sponsor: University of Oklahoma
Current Primary Outcome: Time to ovulation with each protocol [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to pregnancy with each protocol [ Time Frame: 2 years ]
- Rate of ovulation with each dose of clomid within each protocol [ Time Frame: 2 years ]
- Delivery, newborn (within 30 days of birth), and at 1 year of life outcomes [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: University of Oklahoma
Dates:
Date Received: November 3, 2009
Date Started: October 2009
Date Completion:
Last Updated: June 8, 2016
Last Verified: June 2016
