Embryo Aneuploidies and Ovarian Stimulation

Phase 4

Completed

• Conditions: Embryo Aneuploidies
• Interventions: Procedure: Preimplantation Genetic Diagnosis

• Registration Number: NCT00707525
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-06-30
• Study First Submitted QC: 2008-06-30
• Study First Posted: 2008-07-01
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-25
• Last Update Posted: 2010-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Preimplantation Genetic Diagnosis	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.

Primary Outcome Measures

Name	Time	Method
Embryo aneuploidies	2 cycles

Trial Locations

Locations (1)

Instituto Valenciano de Infertilidad; 🇪🇸 Valencia, Spain