The Luveris In Vitro Fertilization Trial

Infertility Clinical 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00889512
• Other study ID #: 0120080358
• Status: Terminated
• Phase: Phase 4
• Start date: April 2009
• Est. completion date: November 2013

Study information

• Verified date: July 2018
• Source: University Reproductive Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: November 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amenorrhea
• Hyperprolactinemia
• Hypothalamic Amenorrhea
• Infertility

Intervention

Drug:
• Luveris fixed dose
Luveris 75IU daily throughout ovarian stimulation
• Luveris increasing dose
Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG

Locations

Country	Name	City	State
United States	University Reproductive Associates	Hasbrouck Heights	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University Reproductive Associates	EMD Serono

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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