Infertility Clinical Trial
Official title:
Non-interventional Observational Study to Evaluate the Baseline FSH, Ovarian Volume and AFC (Antral Follicle Count) as Prognostic Factors of the Outcome of the In-vitro Fertilization/Intracytosolic Sperm Injection (IVF/ICSI) in Infertile Patients Who Receive r-FSH (GONAL-f®) for Controlled Ovarian Hyperstimulation
This is a phase IV non-interventional, multicentric observational study to evaluate the baseline follicle stimulating hormone (FSH) levels, ovarian volume, antral follicle count (AFC) and age as prognostic factors of the outcome of the in-vitro fertilisation/intracytosolic sperm injection (IVF/ICSI) in infertile subjects receiving Gonal-f for controlled ovarian hyperstimulation (COH).
Treatment of subfertility and infertility by assisted reproduction technologies (ART) such
as IVF and embryo transfer (ET) requires multiple follicular development to increase the
number of female gametes, and the chances of a successful treatment outcome. These
technologies include the stimulation of multiple follicular development by exogenous FSH
administration and the suppression of endogenous luteinizing hormone (LH) secretion by
administration of a GnRH analogue (antagonist or agonist, as required). A single dose of
human chorionic gonadotropin (hCG) is administered to mimic the endogenous LH surge and
induce final oocyte maturation after adequate follicular development. Recombinant-hFSH
(r-hFSH) has been shown to be efficacious in terms of number of oocytes recovered and in
terms of pregnancy rates as compared to urinary-hFSH.
Gonal-f fill-by-mass is available as a liquid formulation that can be administered with the
pen device. The pen device is prefilled and hence the subject does not require to assemble
the device making it simpler to use. The prefilled pen allows the accurate delivery of a
precise dose of r-hFSH in 37.5 International Units (IU) increments.
OBJECTIVES
Primary objective:
- Evaluation of the significance of baseline FSH, ovarian volume and AFC with a model
adjusted for age as prognostic factors of the IVF/ICSI treatment outcome.
This study planned to enrol 500 female subjects undergoing COH for IVF/ICSI-treatment with
Gonal-f. Gonal-f will be administered daily subcutaneously (s.c.) according to the centre's
usual clinical practice, commencing on Days 2 or 3 of the cycle during the stimulation
period. Treatment with Gonal-f will be continued until adequate follicular development has
been achieved with the dose adjusted according to the subject's response, to usually not
higher than 450 IU daily. A single injection of 250 micrograms r-hCG or 5,000 IU up to
10,000 IU hCG would be administered 24-48 hours after the last Gonal-f injection to induce
final follicular maturation. Gonal-f will be started approximately 2 weeks after the start
of an gonadotrophin-releasing hormone (GnRH) agonist treatment, both being continued until
adequate follicular development will be achieved. Oocyte retrieval will be done 34-36 hours
after hCG administration followed by IVF/ICSI treatment according to clinic's protocol. Each
enrolled subject would be followed up until the confirmation of her pregnancy status. Active
follow up of all pregnancies will be performed, including those subjects withdrawn from the
study.
;
Observational Model: Cohort, Time Perspective: Prospective
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