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

Embryo Kinetics Clinical Trial

Official title:

Embryo Kinetcis From Embryos Deriving From Egg Donation Cycle With Different Stimulation Protocol: Recombinant FSH vs Human FSH

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01678651
• Other study ID #: MAD-NB-08-2012-01
• Status: Terminated
• Phase: N/A
• First received: August 31, 2012
• Last updated: February 23, 2016
• Start date: August 2012
• Est. completion date: February 2013

Study information

• Verified date: March 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• 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

• Embryo Kinetics

Intervention

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

Locations

Country	Name	City	State
Spain	Insituto Valenciano de Infertilida	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of cell cleavage	Analysis of cell cleavage	February 2012	No
Secondary	Embryo and oocyte morphology	Analysis of all oocytes	February 2012	No
Secondary	Outcome rates (implantation, pregnancy and miscarriage rate)	Time requierd to know all the implantation, pregnancy and miscarriage rate	February 2012	No