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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
IVI Madrid
ClinicalTrials.gov Identifier:
NCT01678651
First received: August 31, 2012
Last updated: February 23, 2016
Last verified: March 2015
  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

Resource links provided by NLM:


Further study details as provided by IVI Madrid:

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


Enrollment: 80
Study Start Date: August 2012
Study Completion Date: February 2013
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   (Adult)
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
Madrid, Spain, 28023
Sponsors and Collaborators
IVI Madrid
  More Information

Responsible Party: IVI Madrid
ClinicalTrials.gov Identifier: NCT01678651     History of Changes
Other Study ID Numbers: MAD-NB-08-2012-01 
Study First Received: August 31, 2012
Last Updated: February 23, 2016
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by IVI Madrid:
time-lapse, FSH, kinetics

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

ClinicalTrials.gov processed this record on August 23, 2016