NCT01016210

Brief Summary

To explore whether recombinant LH (rLH) supplementation (Leuveris) to recombinant follicle stimulating hormone (rFSH) following GnRH antagonist treatment has an advantage in infertile women with advanced reproductive ageing undergoing IVF-ET.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2010

Typical duration for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

2.1 years

First QC Date

November 18, 2009

Last Update Submit

January 16, 2014

Conditions

Pregnancy Result Rape

Keywords

pregnancyIVF

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    Starting February 2010

Secondary Outcomes (1)

  • Fertilization rate

    Starting February 2010 till April 2013

Study Arms (2)

60 infertile women

EXPERIMENTAL

Candidates for IVF-ET treatment

Drug: Leuveris

control

NO INTERVENTION

no treatment

Interventions

LeuverisDRUG

IV

60 infertile women

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female candidate to IVF
  • between 30-45 years old

You may not qualify if:

  • not included for fertilization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poriya hospital

Tiberias, 15208, Israel

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 19, 2009

Study Start

February 1, 2010

Primary Completion

March 1, 2012

Study Completion

April 1, 2013

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

IL(1)