Ovulation Induction Clinical Trial
Official title:
Prospective Multi-centre Observational Study to Determine the Mono-bifollicular Development in Infertile Women Subjected to Ovulation Induction With Follitropin α
This is a prospective and multicentric observational study to determine the real mono-bifollicular development rate that is obtained under normal care conditions following ovulation induction (OI) treatment with follitropin-alpha filled by mass prescribed in accordance with standard practice.
In women with infertility due to anovulation, the main purpose of ovulation induction (OI)
consists in inducing the mono or bifollicular and the subsequent ovulation in order to
achieve pregnancy. The availability of recombinant gonadotropins obtained using genetically
engineered techniques has meant a decisive and clear pharmacological advancement. Use of
recombinant human follicle stimulating hormone (r-hFSH) offers a greater effectiveness
(greater number of follicles/ ovocytes and a higher pregnancy rate) and efficiency (fewer
number of blisters, fewer stimulation days; fewer number of cancellations and complications)
in programmed coitus and artificial insemination like in-vitro fertilisation (IVF)/intra
cytoplasmic sperm injection (ICSI) techniques. Further advances in obtaining better products
for ovarian stimulation has led to production of a recombinant FSH (follitropin alpha)
filled by mass preparation. This hormone becomes the most consistent and precise
gonadotropin due to improvements in its quantification process.
Today, despite having accurate and modern tools for ovulation induction, in daily practice,
doctors continue to "fight" against two old problems of assisted reproduction: multiple
pregnancies and ovarian hyperstimulation syndrome (OHSS). Application of assisted
reproduction techniques (ARTs) and the use of medication that induce ovulation, risk
producing gestations and multiple births with a higher frequency than those observed in
spontaneous gestations. One of the facts that result in the appearance of such problems is
the high incidence of polycystic ovarian syndrome among the population of women who are
infertile due to anovulation. These subjects are especially sensitive to ovarian
stimulation, which leads to multiple follicular development, a higher risk of
hyperstimulation and higher rates of multiple pregnancies.
Therefore, it seems clear that the search for developing mono or bifollicular cycles is
important in ovarian induction cycles, for the purpose of preventing the above mentioned
multiple pregnancy problems and the risk of OHSS. The intent of this study was to figure out
the real mono-bifollicular development rate that is obtained under normal care conditions
following OI treatment with follitropin alpha filled by mass prescribed in accordance with
standard practice. Therefore, a measure of the efficiency of the product for achieving the
development of one or two follicles. Data was collected from 56 centres of the Autonomous
Communities that accepted this observational study, until achieving a total of 410 ovulation
induction cycles.
OBJECTIVES
Primary objective:
- To find the real proportion of cycles with mono-bifollicular development during the
provision of care involving OI with follitropin alpha filled by mass
Secondary objectives:
- To evaluate if the use of follitropin alpha filled by mass has other clinical benefits
such as a reduction in the number of cancelled cycles, of the dosage and time required
and adverse effects
;
Observational Model: Cohort, Time Perspective: Prospective
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