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NCT00889512 · ClinicalTrials.gov registry record · Phase 4
The Luveris In Vitro Fertilization Trial
A Phase 4 study, sponsored by University Reproductive Associates.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT00889512 is a Phase 4 study that was terminated before completion, run by University Reproductive Associates. The registered enrollment target is 14 participants.
The verdict
NCT00889512, a Phase 4 study, was terminated before completion, sponsored by University Reproductive Associates.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to develop a new protocol using two different types of fertility drugs that is more similar to the way the hormones act in a normal menstrual cycle (period). We are recruiting women who are trying to get pregnant through In Vitro Fertilization (IVF) who either have a high prolactin level (a hormone normally found in your blood that is produced in the brain) or have a condition known as hypothalamic amenorrhea in which one does not get regular periods due to low hormone levels. The ovaries can be stimulated with Follicle Stimulating Hormone (FSH) alone and with FSH and Luteinizing Hormone (LH). FSH causes eggs to be made while LH causes estrogen (hormone) production. The women in this study have low hormone levels and need both FSH and LH. Luveris® (LH hormone) is a new drug approved for egg production and is used in IVF. There is no set amount of LH nor a set protocol for LH use. Therefore, we are testing this new regimen. One group of women will receive a fixed dose of LH throughout their cycle while the other will decrease the dose of FSH while at the same time increasing the LH dose which is what happens in the natural menstrual cycle.
Interventions
- DRUG Luveris fixed dose
- DRUG Luveris increasing dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-04 |
| Est. Completion | 2013-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00889512
The ClinicalTrials.gov registry entry for NCT00889512 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Reproductive Associates, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Luveris fixed dose is the first listed.
NCT00889512 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00889512 about?
NCT00889512 is a clinical study titled "The Luveris In Vitro Fertilization Trial". The purpose of this study is to develop a new protocol using two different types of fertility drugs that is more similar to the way the hormones act in a normal menstrual cycle (period). We are recruiting women who are trying to get pregnant through In Vitro Fertilization (IVF) who either have a hi...
What is the current status of trial NCT00889512?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2009-04. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00889512?
The interventions under investigation include: Luveris fixed dose (DRUG), Luveris increasing dose (DRUG).
Who is sponsoring clinical trial NCT00889512?
This trial is sponsored by University Reproductive Associates, which has 5 total clinical trials registered on ClinicalTrials.gov.
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