The Luveris In Vitro Fertilization Trial

NCT00889512 | Terminated Phase 4 Results

• 1 other identifier: 0120080358
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Hypothalamic Amenorrhea; Hyperprolactinemia

Outcome Measures

Primary Outcomes (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.

  2 years

Study Arms (2)

Luveris Fixed dose

ACTIVE COMPARATOR

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 increasing dose

EXPERIMENTAL

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

Interventions

Luveris fixed dose DRUG

Luveris 75IU daily throughout ovarian stimulation

Luveris Fixed dose

Luveris increasing dose DRUG

Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG

Luveris increasing dose

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Reproductive Associates: lead
• EMD Serono: collaborator

Study Sites (1)

University Reproductive Associates

Hasbrouck Heights, New Jersey, 07604, United States

Location

MeSH Terms

Conditions

Infertility; Hyperprolactinemia

Interventions

Luteinizing Hormone, beta Subunit

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Luteinizing Hormone; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed;

Results Point of Contact

• Title: Dr. Peter G. McGovern
• Organization: University Reproductive Associates

mcgovepg@uranj.com

201-288-6330

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 29, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 7, 2018
• Results First Posted: October 23, 2014

Record last verified: 2018-07

Locations

US (1)