NCT01223079

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

2 years

First QC Date

October 8, 2010

Last Update Submit

March 4, 2013

Conditions

Outcome During r-hFSH StimulationOutcome During r-hFSH and r-hLH Stimulation

Keywords

r-hFSHr-hLH

Outcome Measures

Primary Outcomes (2)

  • Safety and efficacy of r-hFSH protocol

    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

    Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.

    6 months

Secondary Outcomes (4)

  • Number of oocytes retrieved

    6 months

  • Quality of embryos obtained

    6 months

  • Incidences of ovarian hyperstimulation syndrome

    6 months

  • Quality of oocytes obtained

    6 months

Study Arms (2)

r-hFSH (Gonal F)

OTHER

Patients will be treated with r-hFSH throughout the stimulation phase of their first cycle until r-hCG administration.

Drug: r-hFSH

r-hFSH (Gonal F) and r-hLH (Luveris)

OTHER

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

Interventions

r-hFSHDRUG

r-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response

Also known as: Gonal F
r-hFSH (Gonal F)
r-hFSH and r-hLHDRUG

Patients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm.

Also known as: r-hFSH, Gonal F, r-hLH, Luveris
r-hFSH (Gonal F) and r-hLH (Luveris)

Eligibility Criteria

Age21 Years - 32 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age less than or equal to 32 years old
  • BMI\<35
  • Eligible for controlled ovarian simulation
  • 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)
  • Meet all requirements for becoming an egg donor
  • Willingness and ability to participate and comply with study protocol for the duration of the study
  • Baseline FSH\<11

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Assoicates of New Jersey

Morristown, New Jersey, 07960, United States

Location

MeSH Terms

Interventions

follitropin alfaLuteinizing Hormone, beta Subunit

Intervention Hierarchy (Ancestors)

Luteinizing HormoneGonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Richard T Scott, MD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 18, 2010

Study Start

December 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2008

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

US(1)