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The Luveris In Vitro Fertilization Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00889512
Recruitment Status : Terminated (Drug no longer available by manufacturer)
First Posted : April 29, 2009
Results First Posted : October 23, 2014
Last Update Posted : August 7, 2018
EMD Serono
Information provided by (Responsible Party):
Peter McGovern, MD, University Reproductive Associates

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 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 or disease Intervention/treatment Phase
Infertility Hypothalamic Amenorrhea Hyperprolactinemia Drug: Luveris fixed dose Drug: Luveris increasing dose Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : April 2009
Actual Primary Completion Date : May 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Active Comparator: Luveris Fixed dose
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: Luveris increasing 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 until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00889512

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

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Responsible Party: Peter McGovern, MD, Director, University Reproductive Associates Identifier: NCT00889512     History of Changes
Other Study ID Numbers: 0120080358
First Posted: April 29, 2009    Key Record Dates
Results First Posted: October 23, 2014
Last Update Posted: August 7, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases