The Luveris In Vitro Fertilization Trial

This study has been terminated.
(Drug no longer available by manufacturer)
Sponsor:
Collaborator:
EMD Serono
Information provided by (Responsible Party):
Peter McGovern, MD, University Reproductive Associates
ClinicalTrials.gov Identifier:
NCT00889512
First received: April 28, 2009
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Infertility
Hypothalamic Amenorrhea
Hyperprolactinemia
Drug: Luveris fixed dose
Drug: Luveris increasing dose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University Reproductive Associates:

Primary Outcome Measures:
  • The primary outcome will be number of large follicles (16 mm or greater in diameter) and midsize (12-15.5 mm in diameter) in both groups on the day of meeting size criteria for hCG. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes include pregnancy rates, number of follicles, hormone levels on the day of hCG, days of GnRH antagonist, fertilization and implantation rates. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: April 2009
Study Completion Date: November 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
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
Luveris 75IU daily throughout ovarian stimulation
Experimental: Group B
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 until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889512

Locations
United States, New Jersey
University Reproductive Associates
Hasbrouck Heights, New Jersey, United States, 07604
Sponsors and Collaborators
University Reproductive Associates
EMD Serono
  More Information

No publications provided

Responsible Party: Peter McGovern, MD, Director, University Reproductive Associates
ClinicalTrials.gov Identifier: NCT00889512     History of Changes
Other Study ID Numbers: 0120080358
Study First Received: April 28, 2009
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Amenorrhea
Hyperprolactinemia
Infertility
Menstruation Disturbances
Pathologic Processes
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 16, 2014