Embryo Aneuploidies and Ovarian Stimulation

Embryo Aneuploidies Clinical Trial

Official title:

Incidence of EmbyoO Aneuploidies in Natural Versus Stimulated Cycles in the Same Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707525
• Other study ID #: 0607-C-M09-EL
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2008
• Last updated: March 25, 2010
• Start date: February 2008
• Est. completion date: February 2010

Study information

• Verified date: March 2010
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

There is a considerable concern about the effects of controlled ovarian hyperstimulation (COH) for In Vitro Fertilization- Embryo Transfer (IVF-ET) on embryo quality and on the incidence of chromosomal abnormalities in oocytes and embryos.

The main question remaining is if COH may increase the aneuploidies rate in young and healthy women. Therefore, the primary endpoint of the present study is to analyse the incidence of chromosomal abnormalities in this group of patients (oocyte donors), either in oocytes obtained after a natural cycle or in those retrieved after a COH cycle. To get rid of the male factor influence, donated sperm will be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Donor Inclusion Criteria:

• 18 to 35 years old.

• BMI: 18-25Kg/m2

• Regular menstrual cycles

• Normal kariotype

• No previous controlled ovarian hyperstimulation (COH) treatments.

Donor Exclusion Criteria:

• Endometriosis

• Policystic ovarian syndrome

• Recurrent miscarriages.

Recipient Inclusion Criteria

• Aged until 45 years old

• No systemic diseases

• Following egg and sperm donation treatment.

Recipient exclusion criteria:

• Uterine disease (polyps, myomas, mullerian defects)

• Recurrent miscarriages.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aneuploidy
• Embryo Aneuploidies

Intervention

Procedure:
• Preimplantation Genetic Diagnosis
Preimplantation Genetic Diagnosis (PGD) is performed on the embryos resulting from these natural and stimulated cycles.

Locations

Country	Name	City	State
Spain	Instituto Valenciano de Infertilidad	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embryo aneuploidies		2 cycles	No