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Embryo Aneuploidies and Ovarian Stimulation

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT00707525
First received: June 30, 2008
Last updated: March 25, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Embryo Aneuploidies
 Procedure: Preimplantation Genetic Diagnosis
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Incidence of EmbyoO Aneuploidies in Natural Versus Stimulated Cycles in the Same Women.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • Embryo aneuploidies [ Time Frame: 2 cycles ] [ Designated as safety issue: No ]

Study Start Date: February 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Natural cycle oocyte donation
Active Comparator: 2

Stimulated cycle oocyte donation.

  • Long protocol down-regulation with a GnRH agonist, starting on the midluteal phase of the previous cycle with leuprolide acetate (0.2mg/day).
  • Once evidence of downregulation is documented, leuprolide will be halved to 0.1 mg daily.
  • COH with be carried on with gonadotropins (150UI/day of rFSH and 75 UI/day of HP-hMG). The dose can be adjusted according to ovarian response as judged by ultrasound and by serum oestradiol (E 2 ) concentrations.
 Procedure: Preimplantation Genetic Diagnosis
Preimplantation Genetic Diagnosis (PGD) is performed on the embryos resulting from these natural and stimulated cycles.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707525

Locations
Spain
Instituto Valenciano de Infertilidad
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
  More Information

No publications provided by Instituto Valenciano de Infertilidad, Spain

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Elena Labarta, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT00707525     History of Changes
Other Study ID Numbers: 0607-C-M09-EL
Study First Received: June 30, 2008
Last Updated: March 25, 2010
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
aneuploidies, natural cycle, stimulated cycle, preimplantation genetic diagnosis

Additional relevant MeSH terms:
Aneuploidy
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013