Aneuploidy Rate and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH

Aneuploidy Rate Clinical Trial

Official title:

Aneuploidy Rate Impact in Oocyte From Egg Donation Cycle With Different Stimulation Protocol: Recombinant FSH vs Human FSH

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01164943
• Other study ID #: MAD-FB-04-2010-01
• Status: Terminated
• Phase: N/A
• First received: July 16, 2010
• Last updated: February 24, 2016
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: IVI Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Male factor

• Uterine malformations

• genetic alterations

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneuploidy
• Aneuploidy Rate

Intervention

Procedure:
• Stimulation with human FSH
Human FSH
• Stimulation with recombinant FSH
Recombinant FSH

Locations

Country	Name	City	State
Spain	Insituto Valenciano de Infertilida, Spain, Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aneuploidy Rate	Analysis of all nuclei fixed	2011 January	Yes
Secondary	Oocyte morphology	Analysis of all oocytes	2011 january	No
Secondary	Outcome rates (implantation, pregnancy and miscarriage rate)	Time requierd to know all the implantation, pregnancy and miscarriage rate	2011 April	No