29356
document
Principal findings from a multicenter trial investigating the safety of follicular-fluid meiosis-activating sterol for in vitro maturation of human cumulus-enclosed oocytes . OBJECTIVE To evaluate the safety of applying follicular-fluid meiosis-activating sterol ( FF-MAS ) in vitro to immature human oocytes . DESIGN Phase I bicenter , randomized , parallel-group , controlled , partially blinded trial . SETTING Third-level referral academic centers , including reproductive biology and genetics laboratories . PATIENTS Endocrinologically normal women with a medical indication for IVF or intracytoplasmic sperm injection , or healthy volunteers . INTERVENTION ( S ) Subjects were randomized at a ratio 1 to 6 into either conventional GnRH-agonist and recombinant FSH stimulation ( IVO ) for oocyte retrieval , or minimally stimulated in vitro maturation ( IVM ) with the use of recombinant FSH . Retrieved immature oocyte cumulus complexes were cultured for 30 or 36 hours in one of six IVM culture conditions containing FF-MAS ( range , 0.1-20 microM ) . Polar body-extruded oocytes from the IVO and IVM groups were processed for chromosomal analysis . MAIN OUTCOME MEASURE ( S ) The primary endpoint was the incidence of metaphase II stage oocytes with numeric chromosomal abnormalities , using full ( spectral karyotyping ) or partial ( fluorescent in situ hybridization with seven probes ) karyotyping or Giemsa count . A secondary objective was to document the frequency of metaphase II oocytes after IVM with FF-MAS supplements . RESULT ( S ) Oocyte cumulus complexes obtained from the IVO ( mean , 8.9 ) and IVM ( mean , 6.2 ) groups had equal maturation rates . Compared to IVO , exposure of germinal-vesicle oocytes for a maturation period of 30 hours did not increase aneuploidy . An exposure period of 36 hours doubled the aneuploidy rate , but this was significant only for the 20-muM dose of FF-MAS . CONCLUSION Inclusion of 1-10 microM FF-MAS in a 30-hour IVM protocol is safe .
29357
Intervention_Pharmacological
follicular-fluid meiosis-activating sterol
29358
Intervention_Pharmacological
follicular-fluid meiosis-activating sterol ( FF-MAS )
29359
Outcome_Physical
incidence of metaphase II stage oocytes with numeric chromosomal abnormalities
29360
Outcome_Physical
frequency of metaphase II oocytes
29361
Outcome_Mental
equal maturation rates .
29362
Outcome_Physical
aneuploidy .
29363
Outcome_Physical
aneuploidy rate
29364
Participant_Sex
women
29365
Participant_Condition
for IVF or intracytoplasmic sperm injection