Infertility Clinical Trial
Official title:
A Prospective, Multicenter, Investigator Blinded, Randomized, Concurrent Control Study of Efficacy and Tolerability of Two FSH Preparations (Fostimon® Versus Gonal-F®) in Women Undergoing IVF
The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous FSH preparations (Fostimon®, IBSA vs Gonal-F®, Serono Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.
Status | Completed |
Enrollment | 152 |
Est. completion date | May 2006 |
Est. primary completion date | May 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - >/=18 and <40 years old; - BMI between 18 and 30 kg/m2; - less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery); - basal FSH <10 IU/L and E2 <80 pg/mL; - Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through a hysterosalpingogram, sonohysterogram, or hysteroscopic examination; - >10 antral follicles 2-10 mm in size; - Normal or clinically insignificant hematology and blood chemistry values. TSH levels must be within the normal limits for the testing laboratory, or the patient should be euthyroid as determined by the investigator (e.g. normal free thyroxine). TSH can be low secondary to exogenous thyroid medication where patient is euthyroid; - Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule. Exclusion Criteria: - · age <18 and >/=40 years; - primary ovarian failure or women known as poor responders (i.e. requiring more than 300 IU of FSH as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with an E2 serum concentration <1800 pmol/L/500pg/mL); - prior ovarian hyperstimulation syndrome (OHSS), polycystic ovarian syndrome that would normally be started at a lower FSH dose than is initially required by the study (i.e. 300 IU), or likely intolerance to even two days of 300 IU FSH. - one or both ovaries inaccessible for oocyte retrieval; - ovarian cysts >20 mm; - hydrosalpinx that have not been surgically removed or ligated; - stage 3 or 4 endometriosis; - oocyte donation; - implantation of previously frozen embryos; - patients affected by pathologies associated with any contraindication of being pregnant; - hypersensitivity to the study medication; - abnormal bleeding of undetermined origin; - uncontrolled thyroid or adrenal dysfunction; - neoplasias; - severe impairment of renal and/or hepatic function; - use of concomitant medications that might interfere with study evaluations (e.g. nonstudy hormonal medications, prostaglandin inhibitors, psychotropic agents). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Fertility Physicians of Northern California | Palo Alto | California |
United States | San Diego Fertility Center | San Diego | California |
United States | UCSF In Vitro Fertilization | San Francisco | California |
United States | Seattle Reproductive Medicine | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
IBSA Institut Biochimique SA |
United States,
Daya S, Gunby J, Hughes EG, Collins JA, Sagle MA. Follicle-stimulating hormone versus human menopausal gonadotropin for in vitro fertilization cycles: a meta-analysis. Fertil Steril. 1995 Aug;64(2):347-54. — View Citation
Giudice E, Crisci C, Eshkol A, Papoian R. Composition of commercial gonadotrophin preparations extracted from human post-menopausal urine: characterization of non-gonadotrophin proteins. Hum Reprod. 1994 Dec;9(12):2291-9. — View Citation
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Howles CM, Loumaye E, Giroud D, Luyet G. Multiple follicular development and ovarian steroidogenesis following subcutaneous administration of a highly purified urinary FSH preparation in pituitary desensitized women undergoing IVF: a multicentre European phase III study. Hum Reprod. 1994 Mar;9(3):424-30. — View Citation
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Smitz J, Devroey P, Braeckmans P, Camus M, Khan I, Staessen C, Van Waesberghe L, Wisanto A, Van Steirteghem AC. Management of failed cycles in an IVF/GIFT programme with the combination of a GnRH analogue and HMG. Hum Reprod. 1987 May;2(4):309-14. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint is the total number of oocytes retrieved. | |||
Secondary | Total FSH dose (IUs);number of days of FSH stimulation and stimulation duration;number of follicles >14 mm on the day of hCG injection; | |||
Secondary | 17-ß estradiol (E2) serum concentration on the day of hCG injection;cancellation rate with reasons; | |||
Secondary | Fertilization rate: number of 2PN (or already cleaved) embryos; | |||
Secondary | Total number of embryos,number transferred, frozen and discarded;implantation rate;number of transferred embryos; clinical pregnancy rate, per stimulated cycle, per oocyte retrieval and per embryo transfer. |
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