NCT01678651

Brief Summary

Different kinetics markers have been proposed to select embryos with higher implantation rates. The effect of external factors on these markers, such as the stimulation protocol should be analyzed. There are two different types of FSH that are commonly used for in vitro fertilization (IVF) in egg donation cycles, recombinant FSH and human FSH. The effect of each kind of hormone on embryo kinetcis is still unknown. The aim of this study is to observe if there is a difference in embryo kinetics and morphology as well as oocyte morphological parameters between the two types of FSH and therefore to analyze if such markers can be used despite of the stimulation protocols chosen.

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 Aug 2012

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 24, 2016

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

August 31, 2012

Last Update Submit

February 23, 2016

Conditions

Embryo Kinetics

Keywords

time-lapse, FSH, kinetics

Outcome Measures

Primary Outcomes (1)

  • time of cell cleavage

    Analysis of cell cleavage

    February 2012

Secondary Outcomes (2)

  • Embryo and oocyte morphology

    February 2012

  • Outcome rates (implantation, pregnancy and miscarriage rate)

    February 2012

Study Arms (2)

Human FSH

ACTIVE COMPARATOR

Human FSH

Procedure: Stimulation with human FSH

Recombinant FSH

ACTIVE COMPARATOR

Recombinant FSH

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

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
SPONSOR

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 5, 2012

Study Start

August 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 24, 2016

Record last verified: 2015-03

Locations

ES(1)