Back to resultsThe Luveris In Vitro Fertilization Trial
Primary Purpose
Infertility, Hypothalamic Amenorrhea, Hyperprolactinemia
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Luveris fixed dose
Luveris increasing dose
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- University Reproductive Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Luveris Fixed dose
Luveris increasing dose
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00889512
First Posted
April 28, 2009
Last Updated
July 9, 2018
Sponsor
University Reproductive Associates
Collaborators
EMD Serono
1. Study Identification
Unique Protocol Identification Number
NCT00889512
Brief Title
The Luveris In Vitro Fertilization Trial
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Drug no longer available by manufacturer
Study Start Date
April 2009 (Actual)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Reproductive Associates
Collaborators
EMD Serono
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Hypothalamic Amenorrhea, Hyperprolactinemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Luveris Fixed dose
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Luveris increasing dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Luveris fixed dose
Intervention Description
Luveris 75IU daily throughout ovarian stimulation
Intervention Type
Drug
Intervention Name(s)
Luveris increasing dose
Intervention Description
Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
University Reproductive Associates
City
Hasbrouck Heights
State/Province
New Jersey
ZIP/Postal Code
07604
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Luveris In Vitro Fertilization Trial
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