RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF (NCT01035099) | Clinical Trial Compass
CompletedPhase 4
RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF
United States41 participantsStarted 2009-11
Plain-language summary
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.
Who can participate
Age range
19 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female breast cancer patient with breast cancer diagnosis after surgery and before undergoing chemotherapy desiring fertility preservation with oocyte or embryo cryopreservation
* Healthy subject according to documented medical history and physical examination who has been diagnosed with breast cancer (estrogen and progesterone receptor positive and/or negative)
* Age less that 45 years at time of informed consent
* Verbal or written clearance from medical or surgical oncologist to undergo controlled ovarian hyperstimulation-IVF
* Delay to chemotherapy treatment will not jeopardize cancer treatment outcome
* Ovarian stimulation will not affect cancer treatment plan
* Transvaginal ultrasound scan (US) within one month of starting stimulation with no clinically significant pelvic mass
* Serum FSH level (Day 2-4) less than 25
* Negative pregnancy test prior to beginning Letrozole or gonadotropin therapy
* Willing and able to comply with the protocol
* Voluntary provision of written informed consent, prior to any study related procedure that was not part of normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to her future medical care
* Willingness to provide follow-up information on herself and babies born as part of this study
Exclusion Criteria:
* Patients not medically cleared by their oncologist
* Patients with stage IV breast cancer based on the poor prognosis, general health of the patient…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mature Oocyte Yield
Timeframe: 1 to 2 months
2
Percent of Mature Oocyte Yield
Timeframe: 1 to 2 months
Trial details
NCT IDNCT01035099
SponsorWeill Medical College of Cornell University