A randomized, double-blind, placebo-controlled trial of heparin and aspirin for women with in vitro fertilization implantation failure and antiphospholipid or antinuclear antibodies.
OBJECTIVE
To investigate whether heparin and low-dose aspirin increase the pregnancy rate in antiphospholipid antibody or antinuclear antibody-seropositive women with IVF implantation failure.


METHODS
A double-blind, randomized, transfer-by-transfer of fresh or cryopreserved embryos, crossover trial.A hospital infertility clinic and associated IVF service.


METHODS
Women seropositive for at least one antiphospholipid (APA), antinuclear (ANA), or beta(2) glycoprotein I autoantibody and >or=10 embryos transferred without achieving pregnancy (n = 143).


METHODS
Subcutaneous unfractionated heparin (5000 IU b.i.d.) and aspirin (100 mg daily) (158 transfers of 296 embryos) or placebo (142 transfers of 259 embryos) from the day of embryo transfer.


METHODS
Fetal heart per embryo transferred (implantation rate).


RESULTS
There was no significant difference in pregnancy rates or implantation rates between treated and placebo cycles; for example, fetal hearts per embryo transferred implantation rates were 6.8% (20/296) and 8.5% (22/259), respectively, and the generalized estimating equation covariate adjusted relative pregnancy rate was 0.65 (95% confidence interval, 0.33-1.28). The implantation rate for seropositive trial participants (42/555, 7.6%) compared favorably with that for IVF implantation-failure patients continuing treatment outside the trial (147/3237, 4.5%).


CONCLUSIONS
Heparin and aspirin did not improve pregnancy or implantation rates for APA-positive or ANA-positive patients with IVF implantation failure.
Stern
Catharyn
C
Royal Women's Hospital, Carlton, Victoria, Australia. kate.stern@rwh.org.au
Chamley
Lawrence
L
Norris
Helen
H
Hale
Lyndon
L
Baker
H W Gordon
HW
D000328:Adult; D000974:Antibodies, Antinuclear / Q000032:analysis*; D017152:Antibodies, Antiphospholipid / Q000032:analysis*; D000925:Anticoagulants / Q000627:therapeutic use*; D001241:Aspirin / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D010064:Embryo Implantation; D005260:Female; D005307:Fertilization in Vitro; D006493:Heparin / Q000627:therapeutic use*; D006801:Humans; D010919:Placebos; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D011247:Pregnancy; D018873:Pregnancy Rate; D017211:Treatment Failure
D000974:Antibodies, Antinuclear; D017152:Antibodies, Antiphospholipid; D000925:Anticoagulants; D010919:Placebos; D010975:Platelet Aggregation Inhibitors; D006493:Heparin; D001241:Aspirin