Embryo Kinetics and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Instituto Valenciano de Infertilidad, IVI VALENCIA.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT01678651
First received: August 31, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Embryo Kinetics
Procedure: Stimulation with human FSH
Procedure: Stimulation with recombinant FSH

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Embryo Kinetcis From Embryos Deriving From Egg Donation Cycle With Different Stimulation Protocol: Recombinant FSH vs Human FSH

Further study details as provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:

Primary Outcome Measures:
  • time of cell cleavage [ Time Frame: February 2012 ] [ Designated as safety issue: No ]
    Analysis of cell cleavage


Secondary Outcome Measures:
  • Embryo and oocyte morphology [ Time Frame: February 2012 ] [ Designated as safety issue: No ]
    Analysis of all oocytes

  • Outcome rates (implantation, pregnancy and miscarriage rate) [ Time Frame: February 2012 ] [ Designated as safety issue: No ]
    Time requierd to know all the implantation, pregnancy and miscarriage rate


Estimated Enrollment: 80
Study Start Date: August 2012
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Human FSH
Human FSH
Procedure: Stimulation with human FSH
Human FSH
Active Comparator: Recombinant FSH
Recombinant FSH
Procedure: Stimulation with recombinant FSH
Recombinant FSH

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Male factor
  • Uterine malformations
  • genetic alterations
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678651

Locations
Spain
Insituto Valenciano de Infertilida Recruiting
Madrid, Spain, 28023
Contact: Natalia Basile, PhD    +34911802900 ext 24516    natalia.basile@ivi.es   
Contact: Fernando Bronet, PhD    +34911802900 ext 24145    fernando.bronet@ivi.es   
Principal Investigator: Eva Martínez, PhD         
Principal Investigator: David Agudo, PhD         
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
  More Information

No publications provided

Responsible Party: Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT01678651     History of Changes
Other Study ID Numbers: MAD-NB-08-2012-01
Study First Received: August 31, 2012
Last Updated: August 31, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:
time-lapse, FSH, kinetics

Additional relevant MeSH terms:
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014