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

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ClinicalTrials.gov Identifier: NCT01678651
Recruitment Status : Terminated
First Posted : September 5, 2012
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
IVI Madrid

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.

Condition or disease Intervention/treatment Phase
Embryo Kinetics Procedure: Stimulation with human FSH Procedure: Stimulation with recombinant FSH Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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
Study Start Date : August 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. time of cell cleavage [ Time Frame: February 2012 ]
    Analysis of cell cleavage


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

  2. Outcome rates (implantation, pregnancy and miscarriage rate) [ Time Frame: February 2012 ]
    Time requierd to know all the implantation, pregnancy and miscarriage rate



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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

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

Responsible Party: IVI Madrid
ClinicalTrials.gov Identifier: NCT01678651     History of Changes
Other Study ID Numbers: MAD-NB-08-2012-01
First Posted: September 5, 2012    Key Record Dates
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