Study question: To compare the effect of oral Calcium dobesilate to oral cabergoline
in the prevention of ovarian hyperstimulation syndrome (OHSS) in
high-risk women underwent intracytoplasmic sperm injection (ICSI).
Summary answer: Ovarian hyperstimulation syndrome was significantly
lower in dobesilate group than in cabergoline group. severe OHSS was more
common in cabergoline group
What is known already: Ovarian Hyperstimulation Syndrome (OHSS) is one
of the most serious complication of ovulation induction. The pathophysiology
of OHSS is characterised by increased capillary permeability, leading to
leakage of fluid from the vascular compartment, with third space fluid accumulation.
one of the most accepted theory for this is an increase in vascular
endothelial growth factor (VEGF).
Cabergoline has been studied as a potential drug for use in the prevention
of OHSS due to its role in suppression of (VEGF). Calcium dobesilate is used
in the treatment of diabetic retinopathy and chronic venous insufficiency and in
vivo proved to inhibit VEGF
Study design, size, duration: This was a randomized single blind study in
Benha university hospital with two hundred high-risk patients undegoing ICSI
or IVF from April 2014 till December 2015 were randomly divided into two
groups. The women with even numbers in Group I and Group II with odd numbers.
Sample size calculation was
Z2 x (p) x (1 – p)
SS = _____________
C2
SS = Sample Size.
Z = Z-value.
P = Percentage of population affected.
C = Confidence interval.
Participants/materials, setting, methods: Two hundred high-risk patients undegoing
ICSI or IVF characterized by presence of more than 20 follicles by
ultrasound, E2 more than 3000 pg/ml or retrieval of more than 15 follicles were
randomly divided into 2 groups. The women with even numbers (100) in Group
I and were administered calcium dobesilate at day of HCG injection and for 2
weeks while Group II received Cabergoline at day of HCG injection and for
eight days.
Main results and the role of chance: One hundred patients in each group
completed the study.
Follow-up of the patients showed that OHSS was significantly lower in the
calcium dobesilate group (12/100) than cases in cabergoline group (28/100) (p
= 0.005) and that severe OHSS cases were significantly more common in the
cabergoline group (13/100) than in the calcium dobesilate group (2/100) (P <
0.003).
All OHSS cases in both groups were early onset OHSS. The patients with
mild and moderate OHSS from both the study groups were monitored on an
out–patient basis until the resolution of signs and symptoms. All the severe
cases in our study were grade 4 of Golan et al. criteria and treated as outpatient.
Only one case in the cabergoline group was hospitalized with oliguria (urine
output 45%).
Fertilization rates, the implantation, chemical and clinical pregnancy and
multiple pregnancy rates as well as the number of miscarriages were similar
in both groups.
Limitations, reasons for caution: 1- single blind, not double blind study.
2- study no. is a bit small.
3- No control, but this was for ethical reasons as we cannot leave these
patients to face the hazards of OHSS.
Wider implications of the findings: Cabegoline showed some success for the
prevention of OHSS in the literature with some papers agree and others disagree
with its value but for the best of our knowledge this is the first study to
try calcium dobesilate as a preventive drug for OHSS and to compare it with
cabergoline
Trial registration number: NCT02271360 |
