Sterility Clinical Trial
Official title:
Prospective, Randomized Open Trial to Evaluate the Efficacy of an Ovarian Stimulation Protocol Based on FSH Receptor Genotype
Available data from in vitro studies and clinical trials indicate that genetic factors play
a significant role in the success of controlled ovarian stimulation (COS) prior to in vitro
fertilization - embryo trandfer (IVF-ET). Women with the FSHR Ser680Asn Ser/Ser genotype
make up between 13% and 26% of women undergoing IVF-ET and are characterised by higher basal
FSH serum concentrations, the need for a higher amount of FSH for COS, and a higher risk of
poor response to COS and cycle cancellation.
The investigators therefore intend to perform a study to investigate whether a
dose-intensified COS protocol based on FSHR genotype status in women with the FSHR Ser680Asn
Ser/Ser genotype is more effective than routine management in terms of
- the mean number of follicles
- the mean number of embryos
- the rate of poor responders
- the rate of women with cycle cancellations, and v) the clinical pregnancy rates.
Eligible women will be randomized to a stimulation protocol characterised by a longer
duration and increased dosage of FSH stimulation (group A) or a standard stimulation
protocol (group B).
Women in group A will undergo controlled ovarian stimulation according to the following
protocol:
Pituitary down-regulation will be achieved using buserelin (Suprefact®, Hoechst, Frankfurt,
Germany) at a fixed daily dose of 200 mg s.c., according to a long agonist protocol,
starting on day 2 of the normal menstrual cycle. Treatment with r-hFSH (Gonal-F®, Serono
Austria GmbH, Vienna, Austria) will be started in women with serum E2 concentrations <200
pmol/l and no follicles >15 mm in diameter or ovarian cysts on ultrasonographic examination.
The initial r-hFSH dose will be 250 IU s.c. daily for 5 days, after which the dose will be
increased to a maximum of 450 IU per day using a step-up protocol with steps of 50 IU/day.
Once the leading follicle has reached a diameter of 14 mm, patients will receive r-hLH
(lutropin alfa; Luveris®, Serono Austria GmbH, Vienna, Austria) at a dose of 75 IU s.c. for
a maximum of 10 days. A dose of 75 IU LH per day was chosen based on findings from a
controlled, prospective, dose-finding study in gonadotrophin-deficient women (WHO I
classification) (7). Ovulation will be induced by administration of HCG (Profasi®, Serono
Austria GmbH, Vienna, Austria), 10 000 IU i.m. or s.c., when at least two follicles have
reached a diameter of >17 mm.
Oocyte retrieval will be performed by ultrasound-guided follicular aspiration techniques
34-38 h after administration of HCG. IVF will be performed according to standard practices
at our institution. A maximum of three embryos will be transferred 48 h after oocyte
retrieval (ESHRE Committee on Good Clinical and Laboratory Practice, 1995 ). Patients will
receive micronized progesterone, 600 mg/day, by vaginal administration for at least the
first 3 weeks of pregnancy, beginning on the day of embryo transfer.
Women in group B will undergo ovarian hyperstimulation according to the following protocol:
No pituitary down-regulation will be performed. Treatment with r-hFSH (Gonal-F®, Serono
Austria GmbH, Vienna, Austria) will be started in women with serum E2 concentrations <200
pmol/l and no follicles >15 mm in diameter or ovarian cysts on ultrasonographic examination.
The r-hFSH dose will be 150 IU s.c. daily for 11 consecutive days.
Once the leading follicle has reached a diameter of 14 mm, patients will receive r-hLH
(lutropin alfa; Luveris®, Serono Austria GmbH, Vienna, Austria) at a dose of 75 IU s.c. for
a maximum of 10 days. A dose of 75 IU LH per day was chosen based on findings from a
controlled, prospective, dose-finding study in gonadotrophin-deficient women (WHO I
classification) (European Recombinant Human LH Study Group, 1998 ). Ovulation will be
induced by administration of HCG (Profasi®, Serono Austria GmbH, Vienna, Austria), 10 000 IU
i.m. or s.c., when at least two follicles have reached a diameter of >17 mm.
Oocyte retrieval will be performed by ultrasound-guided follicular aspiration techniques
34-38 h after administration of HCG. IVF will be performed according to standard practices
at our institution. A maximum of three embryos will be transferred 48 h after oocyte
retrieval (ESHRE Committee on Good Clinical and Laboratory Practice, 1995 ). Patients will
receive micronized progesterone, 600 mg/day, by vaginal administration for at least the
first 3 weeks of pregnancy, beginning on the day of embryo transfer.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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