NCT01037699

Brief Summary

To analyse the impact on cycle outcome of LH supplementation in ovarian stimulation controlled with a GnRH antagonist in two ages groups: patients upto 35 years old, and patients aged between 36 and 39 years old.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
720

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2005

Typical duration for phase_3

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

January 1, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

Enrollment Period

3.2 years

First QC Date

December 21, 2009

Last Update Submit

December 22, 2009

Conditions

Ovarian Stimulation

Keywords

Ovarian stimulationIn Vitro FertilizationLuteinizing HormoneGnRH antagonistImplantation rate in infertile patients undergoing In vitro fertilization and embryo transfer.

Outcome Measures

Primary Outcomes (1)

  • Implantation rate

    4 weeks after embryo transfer

Study Arms (4)

FSH YOUNGER

ACTIVE COMPARATOR
Drug: rFSH: Follicle Stimulating Hormone

FSH OLDER

ACTIVE COMPARATOR
Drug: rFSH: Follicle Stimulating Hormone

FSH LH YOUNGER (Recombinant Luteotrophin alfa)

EXPERIMENTAL
Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)

FSH LH OLDER

EXPERIMENTAL
Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)

Interventions

rFSH: Follicle Stimulating HormoneDRUG
FSH YOUNGER
rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)DRUG
FSH LH YOUNGER (Recombinant Luteotrophin alfa)

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • st-2nd IVF cycle.
  • Age until 39 years old
  • BMI: 18-29.9.
  • Basal FSH \< 12 IU/L

You may not qualify if:

  • LH:FSH \> 2 (PCO)
  • Low response background (\< 5 oocytes)
  • Endometrioma
  • Recurrent pregnancy loss
  • Any preimplantational genetic diagnosis indication
  • Any systemic, metabolic or endocrinological disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Valencia

Valencia, Valencia, 46117, Spain

Location

Study Officials

  • Ernesto Bosch, MDPhD

    IVI Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2009

First Posted

December 23, 2009

Study Start

January 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

December 23, 2009

Record last verified: 2009-12

Locations

ES(1)