The Luveris In Vitro Fertilization Trial
Condition: Infertility; Hypothalamic Amenorrhea; Hyperprolactinemia
MeSH terms: Hyperprolactinemia; Infertility; Amenorrhea
Intervention: Luveris fixed dose; Luveris increasing dose
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Maximum age: 38 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.