Back to resultsAneuploidy Rate and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH
Primary Purpose
Aneuploidy Rate
Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Stimulation with human FSH
Stimulation with recombinant FSH
Sponsored by
About this trial
This is an interventional treatment trial for Aneuploidy Rate
Eligibility Criteria
Inclusion Criteria:
- Egg donation cycles with more than 8MII in oocyte retrieval day
Exclusion Criteria:
- Male factor
- Uterine malformations
- genetic alterations
Sites / Locations
- Insituto Valenciano de Infertilida, Spain, Madrid
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Human FSH
Recombinant FSH
Arm Description
Outcomes
Primary Outcome Measures
Aneuploidy Rate
Analysis of all nuclei fixed
Secondary Outcome Measures
Oocyte morphology
Analysis of all oocytes
Outcome rates (implantation, pregnancy and miscarriage rate)
Time requierd to know all the implantation, pregnancy and miscarriage rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01164943
Brief Title
Aneuploidy Rate and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH
Official Title
Aneuploidy Rate Impact in Oocyte From Egg Donation Cycle With Different Stimulation Protocol: Recombinant FSH vs Human FSH
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IVI Madrid
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Several stimulation protocols have been used in in vitro fertilization (IVF) in a cycle of egg donation; recombinant FSH and human FSH are included. The effect of each kind of hormone on aneuploidy rate it is unknown. If there was an increase on aneuploidy rate of one of these stimulation protocols, there will be a negative effect on the successful rates in the egg donation cycles. The aim of this study is to observe if there is a different in aneuploidy rate and morphological oocyte parameters between different stimulation protocols.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneuploidy Rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Human FSH
Arm Type
Active Comparator
Arm Title
Recombinant FSH
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Stimulation with human FSH
Intervention Description
Human FSH
Intervention Type
Procedure
Intervention Name(s)
Stimulation with recombinant FSH
Intervention Description
Recombinant FSH
Primary Outcome Measure Information:
Title
Aneuploidy Rate
Description
Analysis of all nuclei fixed
Time Frame
2011 January
Secondary Outcome Measure Information:
Title
Oocyte morphology
Description
Analysis of all oocytes
Time Frame
2011 january
Title
Outcome rates (implantation, pregnancy and miscarriage rate)
Description
Time requierd to know all the implantation, pregnancy and miscarriage rate
Time Frame
2011 April
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Egg donation cycles with more than 8MII in oocyte retrieval day
Exclusion Criteria:
Male factor
Uterine malformations
genetic alterations
Facility Information:
Facility Name
Insituto Valenciano de Infertilida, Spain, Madrid
City
Madrid
ZIP/Postal Code
28023
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Aneuploidy Rate and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH
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