Embryo Aneuploidies and Ovarian Stimulation

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status and phase: Completed; Phase 4

Conditions: Embryo Aneuploidies

Treatments: Procedure: Preimplantation Genetic Diagnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT00707525

0607-C-M09-EL

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

1

No Intervention group

Description:

Natural cycle oocyte donation

2

Active Comparator group

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.

Treatment:

Procedure: Preimplantation Genetic Diagnosis