RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01035099|
Recruitment Status : Recruiting
First Posted : December 18, 2009
Last Update Posted : May 1, 2017
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Infertility||Drug: Letrozole|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2019|
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
- percent of mature oocyte yield [ Time Frame: 1-2 month ]The percentage of mature oocyte obtained will be compared from both arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035099
|Contact: Eden Rauch, MDfirstname.lastname@example.org|
|Contact: Rodriq Stubbs, NPemail@example.com|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10021|
|Contact: Eden Rauch, MD 646-962-3327 firstname.lastname@example.org|
|Contact: Rodriq Stubbs, NP 646-962-3276 email@example.com|
|Principal Investigator: Glenn Schattman, MD|
|Principal Investigator:||Glenn Schattman, MD||Weill Cornell Medical Cornell|