Authors |
B. Urman, B.
Ata, K. Yakin, C. Alatas, S. Aksoy, R. Mercan and B. Balaban |
Journal |
Human Reproduction |
Year of publication |
2009 |
Country |
Turkey |
Period |
From January 2006 to May 2008. |
Study Designer |
Prospective randomized study |
Randomization |
Computer generated randomization
prepared by one of the researchers. The study subjects were randomized in
blocks of 10; that is, of every 10 randomized subjects, five were allocated
to the LMWH arm and five were allocated to the control arm at random. |
Inclusion criteria |
-History of
at least two transfer cycles of previously failed fresh embryos, as
demonstrated with negative levels of human chorionic gonadotropin (hCG) in serum.
-All
previously failed cycles at the American Hospital in Istanbul.
-Female age ≤38
years.
-Fresh
ejaculation sperm to be used for ICSI. No hormonal, clotting or immunological
disorders have been detected.
- Normal
uterine cavity, assessed by hysteroscopy or serum-infused ultrasound.
- Normal
female and male peripheral karyotype |
Exclusion criteria |
Women requiring anticoagulant therapy
for other medical reasons, obvious causes of implantation failure
(transvaginal ultrasound visible hydrosalpinx, fibroids that distort the
uterine cavity, absence of grade I, grade II embryos available for transfer
or clinical or laboratory findings of congenital thrombophilia, or acquired. |
Participant
demographic data |
Women aged between 29 and 41 years and
with ≥2 failed assisted reproduction treatment cycles. |
Types of interventions |
Study group: LMWH (Enoxaparin Sodium,
Clexane, Aventis Pharma) was administered at a dose of 1 mg/kg/day from the
day after oocyte recovery. Control group: it received no medication other
than progesterone gel. |
Results measures |
Primary result: continuous pregnancy
rate. Secondary results: multiple pregnancy, implantation, continuous
pregnancy at> 20 weeks, live births. |
Results |
The results of this pilot study suggest
a potential beneficial effect of LMWH on the clinical outcome of assisted
reproduction therapy (ART) in women with recurrent implantation failure
(RIF). This finding, however, has yet to be corroborated by larger trials. |