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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01678651
First Posted: September 5, 2012
Last Update Posted: February 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
IVI Madrid
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]
    Analysis of cell cleavage


Secondary Outcome Measures:
  • Embryo and oocyte morphology [ Time Frame: February 2012 ]
    Analysis of all oocytes

  • Outcome rates (implantation, pregnancy and miscarriage rate) [ Time Frame: February 2012 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 31, 2012
First Posted: September 5, 2012
Last Update Posted: February 24, 2016
Last Verified: March 2015

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


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