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Embryo Aneuploidies and Ovarian Stimulation

Primary Purpose

Embryo Aneuploidies

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Preimplantation Genetic Diagnosis
Sponsored by
Instituto Valenciano de Infertilidad, IVI VALENCIA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Embryo Aneuploidies focused on measuring aneuploidies, natural cycle, stimulated cycle, preimplantation genetic diagnosis

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Instituto Valenciano de Infertilidad

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

1

2

Arm Description

Natural cycle oocyte donation

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.

Outcomes

Primary Outcome Measures

Embryo aneuploidies

Secondary Outcome Measures

Full Information

First Posted
June 30, 2008
Last Updated
March 25, 2010
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
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1. Study Identification

Unique Protocol Identification Number
NCT00707525
Brief Title
Embryo Aneuploidies and Ovarian Stimulation
Official Title
Incidence of EmbyoO Aneuploidies in Natural Versus Stimulated Cycles in the Same Women.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embryo Aneuploidies
Keywords
aneuploidies, natural cycle, stimulated cycle, preimplantation genetic diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Natural cycle oocyte donation
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Preimplantation Genetic Diagnosis
Intervention Description
Preimplantation Genetic Diagnosis (PGD) is performed on the embryos resulting from these natural and stimulated cycles.
Primary Outcome Measure Information:
Title
Embryo aneuploidies
Time Frame
2 cycles

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Instituto Valenciano de Infertilidad
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22865900
Citation
Labarta E, Bosch E, Alama P, Rubio C, Rodrigo L, Pellicer A. Moderate ovarian stimulation does not increase the incidence of human embryo chromosomal abnormalities in in vitro fertilization cycles. J Clin Endocrinol Metab. 2012 Oct;97(10):E1987-94. doi: 10.1210/jc.2012-1738. Epub 2012 Aug 3.
Results Reference
derived

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Embryo Aneuploidies and Ovarian Stimulation

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