NCT01164943

Brief Summary

Several stimulation protocols have been used in in vitro fertilization (IVF) in a cycle of egg donation; recombinant FSH and human FSH are included. The effect of each kind of hormone on aneuploidy rate it is unknown. If there was an increase on aneuploidy rate of one of these stimulation protocols, there will be a negative effect on the successful rates in the egg donation cycles. The aim of this study is to observe if there is a different in aneuploidy rate and morphological oocyte parameters between different stimulation protocols.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 25, 2016

Status Verified

April 1, 2015

Enrollment Period

2.4 years

First QC Date

July 16, 2010

Last Update Submit

February 24, 2016

Conditions

Aneuploidy Rate

Outcome Measures

Primary Outcomes (1)

  • Aneuploidy Rate

    Analysis of all nuclei fixed

    2011 January

Secondary Outcomes (2)

  • Oocyte morphology

    2011 january

  • Outcome rates (implantation, pregnancy and miscarriage rate)

    2011 April

Study Arms (2)

Human FSH

ACTIVE COMPARATOR
Procedure: Stimulation with human FSH

Recombinant FSH

ACTIVE COMPARATOR
Procedure: Stimulation with recombinant FSH

Interventions

Stimulation with human FSHPROCEDURE

Human FSH

Human FSH
Stimulation with recombinant FSHPROCEDURE

Recombinant FSH

Recombinant FSH

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Egg donation cycles with more than 8MII in oocyte retrieval day

You may not qualify if:

  • Male factor
  • Uterine malformations
  • genetic alterations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Insituto Valenciano de Infertilida, Spain, Madrid

Madrid, Madrid, 28023, Spain

Location

MeSH Terms

Interventions

Follicle Stimulating Hormone, Human

Intervention Hierarchy (Ancestors)

Follicle Stimulating HormoneGonadotropins, PituitaryPituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 19, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 25, 2016

Record last verified: 2015-04

Locations

ES(1)