RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF
The purpose of this study is to compare two different ways to administer Letrozole to determine their effectiveness in blocking estrogen production during ovarian stimulation in patients with breast cancer prior to chemotherapy/radiotherapy so that oocytes or embryos can be cryopreserved and patients can possibly achieve a pregnancy after the treatment of breast cancer.
During standard ovulation stimulation, the estrogen levels will exceed normal levels and may reach 10 times the normal level for a 2 week period. This may not be desirable in breast cancer patients. The study hopes to determine if the investigators can stimulate oocyte development in the conventional way and administer different doses of Letrozole as the oocytes develop, to keep estradiol levels low, increase the number of oocytes the investigators are able to recover, and improve the quality of those oocytes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Open Label Clinical Trial of Fixed Dose Letrozole vs. Titrated Letrozole for In Vitro Fertilization With Cryopreservation of Oocytes and Embryos in Breast Cancer Patients|
- percent of mature oocyte yield [ Time Frame: 1-2 month ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Titrated dose Letrozole
Patients who are randomized to the titrated dose of Letrozole, will start gonadotropins in the evening of day #2 of their menstrual cycle with injectable follicle stimulating hormone (FSH) and human menopausal gonadotropin (HMG). Oral Letrozole will be added to the stimulation in the following titrated regimen.
Letrozole titrated regimen may be started on day 2 of menstrual cycle:
Serum Estradiol level <150 pg/ml- No Letrozole; Serum Estradiol Level 150-250 pg/ml- 2.5mg; Serum Estradiol Level 251-350 pg/ml- 5 mg; Serum Estradiol Level >350 pg/ml - 7.5 mg;
Other Name: Femara- trade name
Active Comparator: Fixed dose Letrozole
Patients who are randomized to fixed dose Letrozole will start Letrozole 5mg daily (orally) on the second day of their menstrual cycle and then gonadotropins on the fourth day of their menstrual cycle.
Fixed dose of 5 mg per day Letrozole will be started on the second day of their menstrual cycle
Other Name: Femara- trade name
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|Contact: Eden Rauch, MDemail@example.com|
|Contact: Rodriq Stubbs, NPfirstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10021|
|Contact: Eden Rauch, MD 646-962-3327 email@example.com|
|Contact: Rodriq Stubbs, NP 646-962-3276 firstname.lastname@example.org|
|Principal Investigator: Glenn Schattman, MD|
|Principal Investigator:||Glenn Schattman, MD||Weill Cornell Medical Cornell|