A Phase 4 interventional study of Luveris fixed dose and Luveris increasing dose in Infertility, Hypothalamic Amenorrhea and Hyperprolactinemia, sponsored by University Reproductive Associates. Terminated at 1 site in United States. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by University Reproductive Associates · Phase 4, Interventional, and Treatment
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 14 is below the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →University Reproductive Associates is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.
Drug: Luveris fixed dose
Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.
Drug: Luveris increasing dose
Luveris 75IU daily throughout ovarian stimulation
Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG
The Primary Outcome Will be Number of Large Follicles (16 mm or Greater in Diameter) and Midsize Follicles (Greater Than 12mm But Less Than 16mm) in Both Groups on the Day of Meeting Size Criteria for hCG.
Time frame: 2 years
| Milestone | Luveris Fixed Dose | Luveris Increasing Dose |
|---|---|---|
| Started | 5 | 9 |
| Completed | 5 | 9 |
| Not completed | 0 | 0 |
| number of follicles | Luveris Fixed Dose | Luveris Increasing Dose |
|---|---|---|
| Large Follicles | 3 (3 to 6) | 3 (2 to 5) |
| Midsize Follicles | 4 (2 to 10) | 4 (1 to 8) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Group B | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | Luveris Fixed Dose | Luveris Increasing Dose | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 9 | 14 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Luveris Fixed Dose | Luveris Increasing Dose | Total |
|---|---|---|---|
| Female | 5 | 9 | 14 |
| Male | 0 | 0 | 0 |
This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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University Reproductive Associates