Impact of follicular-fluid meiosis-activating sterol in an albumin-based formulation on the incidence of human pre-embryos with chromosome abnormalities.

Abstract

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.

DESIGN:

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

SETTING:

Four public IVF clinics in Denmark.

PATIENT(S):

Two hundred eighteen women undergoing IVF donated 483 oocytes.

INTERVENTION(S):

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.

MAIN OUTCOME MEASURE(S):

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.

RESULT(S):

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.

CONCLUSION(S):

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.

• Authors: Anne Loft, Søren Ziebe, Karin Erb, Per Emil Rasmussen, Inge Agerholm, Benedicte Hauge, Mona Bungum, Leif Bungum, Christian Grøndahl, Karsten Lyby
• Journal: Fertility and sterility (Fertil Steril) Vol. 84 Suppl 2 Pg. 1269-76 (Oct 2005) ISSN: 1556-5653 [Electronic] United States
• PMID: 16210020 (Publication Type: Clinical Trial, Phase I, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Albumins
• Cholestenes
• 4,4-dimethylcholesta-8,14,24-trienol

Topics

• Adult
• Albumins (adverse effects, pharmacology)
• Blastomeres (drug effects, pathology)
• Cells, Cultured
• Cholestenes (adverse effects, pharmacology)
• Chromosome Disorders (chemically induced, epidemiology, pathology)
• Confidence Intervals
• Double-Blind Method
• Drug-Related Side Effects and Adverse Reactions
• Embryo, Mammalian (drug effects, pathology)
• Female
• Follicular Fluid (chemistry, physiology)
• Humans
• Incidence
• Meiosis (physiology)
• Odds Ratio
• Prospective Studies