The Luveris In Vitro Fertilization Trial

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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.

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.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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.


Condition

Infertility

Intervention

Luveris fixed dose

Study Arms / Comparison Groups

 Luveris Fixed dose
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

14

Start Date

April 2009

Completion Date

November 2013

Primary Completion Date

May 2013

Eligibility 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.
      

Gender

Female

Ages

18 Years - 38 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00889512

Organization ID

0120080358


Responsible Party

Principal Investigator

Study Sponsor

University Reproductive Associates

Collaborators

 EMD Serono

Study Sponsor

, , 


Verification Date

July 2018