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Microsoft word - van dooren najaar 2004.doc
Low-dose aspirin shows no positive effect in first IVF cycle.
I.M.A. van Dooren, B.C. Schoot, P. Maas, Department of Infertility, Catharina Ziekenhuis Eindhoven and
Maxima Medisch Centrum Veldhoven, the Netherlands Objective
: To determine efficacy of 100 mg Aspirin (Asp) (Calcium Carbasalate, Ascal®) on ovarian response
and pregnancy rates in patients undergoing their first IVF or ICSI cycle.
: A prospective, randomized, double-blind placebo-controlled multicentre trial including 170 patients. Materials/Methods
: A total of 170 patients undergoing their first IVF or IVF/ICSI cycle were randomized to
receive either 100 mg Asp or placebo. We included women according national guidelines, younger then 39 years
with regular cycles. Stratification was performed for primary / secondary infertility.
On cycle day (CD) 3, patients started oral contraceptives; on CD16 a GnRH agonist (Decapeptyl®) and study
medication was given. After a minimum of 14 days with GnRH-a patients started their ovarian stimulation with
gonadotrophins (Puregon®). By regular ultrasound, the moment of HCG injection (Pregnyl® 10.000IE) was
identified. On HCG day, patients started progesterone vaginal capsules (Progestan®). 36 Hours after HCG,
oocyt retrieval took place. Study medication was continued until menstruation or, in case of pregnancy, up till 10
weeks pregnancy. We noted the duration of stimulation, the cumulative FSH dose, number of oocytes, number of
embryos, endometrial thickness on hCG time, incidence of cancellation or OHSS and of course pregnancy rates. Results
Both groups demonstrated similar median age (32 yrs; range 22-44 yrs) and median period of infertility (3yrs
range 1-14 yrs). Cause of infertility was similar in both groups as well as the number of patients having or ICSI
or IVF/ICSI treatment. Median duration of stimulation did not differ between both treatment modalities (Asp-
placebo): (median 12day’s range 9-18 vs. 7-22 days). The cumulative FSH dose was equal in both treatment
arms (median 1800 IU (1050-3300 vs. 1000-5100). The number of dominant follicles at the moment of follicle
aspiration was 9 in the placebo-group (range 0-36) and 10 (0-50) in the Asp group. The median number of
oocytes in both groups were similar (8 [0-30]), as well as the amount of cryo embryo’s (mean 0.8 SEM 0.3) vs.
0.5 (0.15). The median number of viable embryo’s was 5(range 0-25) in the Asp group, vs. 4 (0-20) in the
control group. The endometrial thickness on the moment of HCG did not differ significantly, 9.5mm (6-14) vs.
10mm (6-13) between both treatment modalities. Incidence of cancellation due to low (12 vs., 7 in the placebo
group) or high response (0 vs. 3 in the placebo group) was low, despite fixed treatment regimens. Pregnancy
rates (before 12 weeks and [ongoing]) did not differ significantly between both groups (aspirin group:
31/85=36.5% and [24/85=28.3%]; placebo group: 29/85=34.1% and [25 /85=29.4%]) respectively Conclusions:
A prospective, randomized, double-blind placebo-controlled multicentre trial including 170
patients demonstrates no clinical advantages of low dose aspirin compared to placebo in an IVF treatment
Viatris® Diemen the Netherlands
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