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NCT03011684 · ClinicalTrials.gov registry record · Phase 3
Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial
A Phase 3 study of Infertility, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 309
- Enrollment target
- 1
- Study location
NCT03011684: Recruiting Phase 3 study of Infertility, sponsored by University of California, San Francisco.
NCT03011684 is a Phase 3 study of Infertility that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 309 participants, below the 7,585-participant average among 74 other Infertility trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03011684, a Phase 3 study of Infertility, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 309 participants
- Enrollment target
- 1
- Study location
Study Summary
Latrogenic infertility as a result of cancer treatment has a profound effect on long-term quality of life in survivors of reproductive-age cancers. Oocyte cryopreservation prior to cancer treatment has been associated with improved quality of life, with a potential ability to reduce long-term decision-related regret in cancer survivors. Though letrozole plus gonadotropin and and tamoxifen plus gonadotropin are currently routinely used worldwide in ovarian stimulation cycles for fertility preservation in patients with estrogen-receptor-positive breast cancer, it is not clear which of the two might lead to improved oocyte yield. Improved knowledge about the efficacy of these medications, with regard to oocyte yield, has the potential to significantly improve quality of life in reproductive-age breast cancer survivors.
Primary Outcome
To determine if the assigned stimulation regimen will result in a difference in mature (meiosis II) oocyte yield in patients with breast cancer who undergo ovarian stimulation for fertility preservation. An Effect Size of 3 mature oocytes, based on clinically significant difference of 2 embryos to transfer. An average of 2 embryos are transferred per freeze-thaw cycle. If \~75% of mature oocytes will become embryos that can be frozen, then 3 mature oocytes should yield \~2 embryos for transfer.
Conditions Studied
Interventions
- DRUG Tamoxifen
- DRUG Letrozole
Study Locations (1)
California
- University of California at San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2016-07-21 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 3 |
What NCT03011684 shows while recruiting
NCT03011684 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, below the 7,585-participant average among 74 other Infertility trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Infertility appearing as the primary indexed condition, and to 2 interventions - of which Tamoxifen is the first listed.
NCT03011684 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03011684 about?
NCT03011684 is a clinical study titled "Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial". Latrogenic infertility as a result of cancer treatment has a profound effect on long-term quality of life in survivors of reproductive-age cancers. Oocyte cryopreservation prior to cancer treatment has been associated with improved quality of life, with a potential ability to reduce long-term decisi...
What is the current status of trial NCT03011684?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 2016-07-21. Estimated completion is 2026-03-31.
What conditions does trial NCT03011684 study?
This clinical trial studies the following conditions: Infertility.
What interventions are being tested in trial NCT03011684?
The interventions under investigation include: Tamoxifen (DRUG), Letrozole (DRUG).
Who is sponsoring clinical trial NCT03011684?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03011684 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03011684's enrollment target sits among peer trials
309 32nd of 74 higher than 42 of 74 other Infertility trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infertility trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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