Status:
TERMINATED
The Luveris In Vitro Fertilization Trial
Lead Sponsor:
University Reproductive Associates
Collaborating Sponsors:
EMD Serono
Conditions:
Infertility
Hypothalamic Amenorrhea
Eligibility:
FEMALE
18-38 years
Phase:
PHASE4
Brief 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 recru...
Eligibility Criteria
Inclusion
- 30 women under 38 years old at time of signing Informed Consent Form.
- 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.
- In good general health off of current medications which may confound response to study medications except GnRHa (Lupron Depot).
- Desire to seek pregnancy actively during the study period.
- A normal uterine cavity must have been confirmed by either hysteroscopy or hydrosonogram within two years of entering the study.
- 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.
- Only one treatment cycle per patient will be studied.
Exclusion
- uncorrected thyroid disease.
- heart disease (New York Heart Association Class II or higher).
- a history of, or suspected cervical, endometrial, or breast cancer. A normal Pap smear result within the last 24 months will be required.
- enrolled into other studies that require medications, limit sex, or otherwise prevent compliance with the protocol at the same time.
- to take other medications known to affect reproduction.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00889512
Start Date
April 1 2009
End Date
November 1 2013
Last Update
August 7 2018
Active Locations (1)
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1
University Reproductive Associates
Hasbrouck Heights, New Jersey, United States, 07604