The Luveris In Vitro Fertilization Trial
| Status: | Terminated |
|---|---|
| Conditions: | Women's Studies, Infertility |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 38 |
| Updated: | 8/9/2018 |
| Start Date: | April 2009 |
| End Date: | November 2013 |
The Luveris® In Vitro Fertilization Trial: The Effect of Recombinant Luteinizing Hormone on Follicular Response, Oocyte Quality, and Pregnancy in In-Vitro Fertilization Treatment Cycles in Women Without Endogenous LH Activity.
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.
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.
Inclusion Criteria:
1. 30 women under 38 years old at time of signing Informed Consent Form.
2. Evidence of hypothalamic amenorrhea (irregular menses and FSH and LH <5 mIU/mL),
uncorrected hyperprolactinemia (prolactin levels 10% above the upper limit of normal)
or iatrogenic hypothalamic hypogonadism secondary to GnRHa suppression.
3. In good general health off of current medications which may confound response to study
medications except GnRHa (Lupron Depot).
4. Desire to seek pregnancy actively during the study period.
5. A normal uterine cavity must have been confirmed by either hysteroscopy or
hydrosonogram within two years of entering the study.
6. A semen analysis on the male partner deemed adequate for IVF by the attending
physician within the past year or donor sperm available for insemination.
7. Only one treatment cycle per patient will be studied.
Exclusion Criteria:
1. uncorrected thyroid disease.
2. heart disease (New York Heart Association Class II or higher).
3. a history of, or suspected cervical, endometrial, or breast cancer. A normal Pap smear
result within the last 24 months will be required.
4. enrolled into other studies that require medications, limit sex, or otherwise prevent
compliance with the protocol at the same time.
5. to take other medications known to affect reproduction.
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