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Embryo Aneuploidies and Ovarian Stimulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00707525
First Posted: July 1, 2008
Last Update Posted: March 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA
  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: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Incidence of EmbyoO Aneuploidies in Natural Versus Stimulated Cycles in the Same Women.

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

Primary Outcome Measures:
  • Embryo aneuploidies [ Time Frame: 2 cycles ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707525


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

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
First Submitted: June 30, 2008
First Posted: July 1, 2008
Last Update Posted: March 26, 2010
Last Verified: March 2010

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

Additional relevant MeSH terms:
Aneuploidy
Chromosome Aberrations
Pathologic Processes