The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonist Ovarian Stimulation Protocol

European Hospital

Status and phase: Unknown; Phase 3

Conditions: Embryo's Genetic and Chromosomal Quality

Treatments: Drug: ghrh antagonist (cetrotide/orgalutran); Drug: gnrh agonist (suprefact)

Study type: Interventional

Funder types: Other

Identifiers

NCT01636505

ECK011170

Details and patient eligibility

About

The aim of this study is to performed a randomized controlled trial to evaluate the rate of genetic and chromosomal abnormalities in embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocols.

Patients will be prospectively randomized in two groups: the first undergoing controlled ovarian stimulation in GnRH-agonist long protocol and the second following GnRH-antagonist ovarian stimulation regimen.

The end-points of the study include the number of genetically and chromosomally abnormal embryos, the pregnancy, the implantation and the healthy baby birth rate.

The patients included in PGS program were selected on the base of advanced maternal age, repeated pregnancy lost and implantation failure whereas the patients who were know to carry sex-linked or monogenic disorders were considered for PGD strategy.

The uterine abnormalities, endometriosis and endocrinal diseases were considered to be the exclusion factors.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 46 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients carrier genetic disease
• advanced maternal Age
• repeated IVF failure
• recurrent pregnancy loss

Exclusion criteria

• uterine abnormalities
• endometriosis
• endocrinal diseases

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

short protocol

Active Comparator group

Description:

gnrh agonist versus gnrh antagonist

Treatment:

Drug: ghrh antagonist (cetrotide/orgalutran)

long protocol

Active Comparator group

Treatment:

Drug: gnrh agonist (suprefact)