Impact of follicular-fluid meiosis-activating sterol in an albumin-based formulation on the incidence of human pre-embryos with chromosome abnormalities.
OBJECTIVE
To evaluate the effect of adding follicular-fluid meiosis-activating sterol (FF-MAS) in a novel 0.2% recombinant human albumin-based formulation to cumulus-enclosed oocytes on chromosomal status and development of pre-embryos.


METHODS
Multicenter, prospective, randomized, open (double-blind for vehicle and FF-MAS groups), four parallel groups, controlled trial.


METHODS
Four public IVF clinics in Denmark.


METHODS
Two hundred eighteen women undergoing IVF donated 483 oocytes.


METHODS
Follicle-stimulating hormone/hCG-primed cumulus-enclosed oocytes randomized to 4 hours of exposure to medium with 1 or 10 micromol/L of FF-MAS dissolved in 0.2% recombinant human albumin, medium with 0.2% recombinant human albumin (vehicle control), or medium alone (control) before insemination.


METHODS
Primary endpoint: incidence of human pre-embryos with chromosomal abnormalities. Secondary endpoint: fertilization rate, cleavage rate, and pre-embryo quality assessed after 68 hours of culture.


RESULTS
At pre-embryo level, the overall abnormality rates in the control, vehicle control, and 1- and 10-micromol/L FF-MAS groups were 53%, 39%, 42%, 53%, respectively, and at blastomere level 49%, 44%, 44%, and 48%, respectively. After 20 and 26 hours, the fertilization rates were between 67% and 71% in all groups. No differences in the cleavage rates were observed.


CONCLUSIONS
The concentrations of FF-MAS in a novel 0.2% recombinant human albumin-based formulation of FF-MAS did not increase the risk of chromosomal abnormalities in pre-embryos or blastomeres. No statistically significant differences in fertilization rate, cleavage rate, or number of good quality pre-embryos were found among the four groups.
Loft
Anne
A
The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. aloft@rh.hosp.dk
Ziebe
Søren
S
Erb
Karin
K
Rasmussen
Per Emil
PE
Agerholm
Inge
I
Hauge
Benedicte
B
Bungum
Mona
M
Bungum
Leif
L
Grøndahl
Christian
C
Lyby
Karsten
K
D000328:Adult; D000418:Albumins / Q000009:adverse effects / Q000494:pharmacology*; D001757:Blastomeres / Q000187:drug effects / Q000473:pathology; D002478:Cells, Cultured; D002782:Cholestenes / Q000009:adverse effects / Q000494:pharmacology*; D025063:Chromosome Disorders / Q000139:chemically induced / Q000453:epidemiology* / Q000473:pathology; D016001:Confidence Intervals; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D004622:Embryo, Mammalian / Q000187:drug effects* / Q000473:pathology; D005260:Female; D015571:Follicular Fluid / Q000737:chemistry / Q000502:physiology*; D006801:Humans; D015994:Incidence; D008540:Meiosis / Q000502:physiology*; D016017:Odds Ratio; D011446:Prospective Studies
D000418:Albumins; D002782:Cholestenes; C100324:4,4-dimethylcholesta-8,14,24-trienol