Use of r-hLH (Luveris) in Donors Previously Treated With r-hFSH (Gonal F)

March 4, 2013 updated by: Reproductive Medicine Associates of New Jersey

Use of r-hLH (Luveris) Late Follicular Phase for Controlled Ovarian Stimulation (COS) in Donor Patients Previously Treated With r-hFSH (Gonal F)in a Long Luteal Downregulated Cycle With GnRH Agonist. A Cross-over Study

The purpose of the study is to compare the safety and efficacy of r-hLH to r-hFSH in the late follicular phase of young women undergoing controlled ovarian stimulation for oocyte donation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

While the role of FSH is considered the fundamental driver of folliculogenesis, the role of LH in this process is more controversial. FSH is associated with stimulating growth and recruitment of follicles while LH is associated with the selection of dominant follicles destined for ovulation. We will use an open, prospective, cross-over study to compare the safety and efficacy of two different treatment protocols for controlled ovarian stimulation in egg donors.

20 participants will undergo two cycles of stimulation. The first one will be with r-hFSH though the cycle and the second with r-hFSH then r-hLH. The participants will have 1 month rest cycle between the treatment cycles. r-hFSH doses will be adjusted according to patient response. r-hLH dosing will begin when there are 2 follicles greater than or equal to 14mm in diameter. The does will be 300IU/day and continue until the day of r-hCG administration.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Reproductive Medicine Assoicates of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 32 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age less than or equal to 32 years old
  2. BMI<35
  3. Eligible for controlled ovarian simulation
  4. No PCO-type ovaries (PCO by USS image, >2.1 LH;FSH ratio on cycle day 3, insulin resistance, increase of testosterone over free testosterone)
  5. Meet all requirements for becoming an egg donor
  6. Willingness and ability to participate and comply with study protocol for the duration of the study
  7. Baseline FSH<11

Exclusion Criteria:

  1. Clinically significant systemic disease
  2. Any contraindication to gonadotropin therapy
  3. LH:FSH ratio greater than 3
  4. Pregnancy in the past 3 months
  5. Any medical condition which, in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug
  6. Simultaneous participation in another clinical trial
  7. Known active substance abuse, including tobacco and alcohol (>10 cigarettes/day)
  8. Refusal or inability to comply with protocol
  9. Known poor ovarian response

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: r-hFSH (Gonal F)
Patients will be treated with r-hFSH throughout the stimulation phase of their first cycle until r-hCG administration.
Drug: r-hFSH
r-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response
Other Names:
  • Gonal F
Other: r-hFSH (Gonal F) and r-hLH (Luveris)
Patients will be treated with r-hFSH only until they have 2 follicles greater than or equal to 14mm. Patients will then bring 300IU/day of r-hLH until r-hCG administration.
Drug: r-hFSH and r-hLH
Patients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm.
Other Names:
  • Gonal F
  • r-hFSH
  • r-hLH
  • Luveris

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and efficacy of r-hFSH protocol
Time Frame: 6 months
Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.
6 months
Safety and efficacy of r-hFSH + r-hLH protocol
Time Frame: 6 months
Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of oocytes retrieved
Time Frame: 6 months
Evaluation of the number of oocytes obtained as a function of stimulation protocol.
6 months
Quality of embryos obtained
Time Frame: 6 months
Evaluation of pregnancy rates (clinical and ongoing), delivery rates, multiple pregnancy rates and the number of cancelled cycles.
6 months
Incidences of ovarian hyperstimulation syndrome
Time Frame: 6 months
Evaluation of the potential adverse effects associated with ovarian stimulation
6 months
Quality of oocytes obtained
Time Frame: 6 months
Evaluation of the quality of oocytes obtained as a function of stimulation protocol.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reproductive Medicine Associates of New Jersey

Investigators

  • Principal Investigator: Richard T Scott, MD, Reproductive Medicine Associates of new Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 15, 2010

First Posted (Estimate)

October 18, 2010

Study Record Updates

Last Update Posted (Estimate)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20052361

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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