Clinical Efficacy and Tolerability of Two FSH Preparations (Human FSH Versus rFSH - Follitropin Alpha) in Women Undergoing IVF

NCT ID: NCT00378001

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2006-05-31

Brief Summary

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.

Detailed Description

This is a prospective, multicenter, investigator blinded, randomized, concurrent control, phase III clinical trial. Patients meeting the eligibility requirements of the study will be randomly assigned to receive either the test drug (Fostimon®, IBSA) or the reference drug (Gonal-F®, Serono Inc.). Investigators will be blinded by not allowing them to have any contact with the study medications (supplied in boxes labeled in a manner that does not reveal the content of the boxes), and requesting that patients do not make any statements to the investigator that might indicate the treatment to which they were assigned. Equivalence testing with regard to the primary outcome variable will establish whether the two treatments are indeed similarly effective.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

FSH-IBSA

Intervention Type: DRUG

GONAL-F

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IBSA Institut Biochimique SA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Valerie Baker, MD

Role: PRINCIPAL_INVESTIGATOR

Fertility Physicians of Northern California

Victor Y Fujimoto, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF In Vitro Fertilization

L. Michael Kettel, MD

Role: PRINCIPAL_INVESTIGATOR

San Diego Fertility Center

Michael R Soules, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Reproductive Medicine

Locations

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, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Porter RN, Smith W, Craft IL, Abdulwahid NA, Jacobs HS. Induction of ovulation for in-vitro fertilisation using buserelin and gonadotropins. Lancet. 1984 Dec 1;2(8414):1284-5. doi: 10.1016/s0140-6736(84)92840-x. No abstract available.

Reference Type: BACKGROUND

PMID: 6150318 (View on PubMed)

Loumaye E. The control of endogenous secretion of LH by gonadotrophin-releasing hormone agonists during ovarian hyperstimulation for in-vitro fertilization and embryo transfer. Hum Reprod. 1990 May;5(4):357-76. doi: 10.1093/oxfordjournals.humrep.a137105. No abstract available.

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Reference Type: BACKGROUND

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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. doi: 10.1093/oxfordjournals.humrep.a136540.

Reference Type: BACKGROUND

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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. doi: 10.1093/oxfordjournals.humrep.a138440.

Reference Type: BACKGROUND

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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. doi: 10.1093/oxfordjournals.humrep.a138522.

Reference Type: BACKGROUND

PMID: 8006130 (View on PubMed)

Wikland M, Borg J, Hamberger L, Svalander P. Simplification of IVF: minimal monitoring and the use of subcutaneous highly purified FSH administration for ovulation induction. Hum Reprod. 1994 Aug;9(8):1430-6. doi: 10.1093/oxfordjournals.humrep.a138724.

Reference Type: BACKGROUND

PMID: 7989500 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7615113 (View on PubMed)

Golan A, Ron-el R, Herman A, Soffer Y, Weinraub Z, Caspi E. Ovarian hyperstimulation syndrome: an update review. Obstet Gynecol Surv. 1989 Jun;44(6):430-40. doi: 10.1097/00006254-198906000-00004. No abstract available.

Reference Type: BACKGROUND

PMID: 2660037 (View on PubMed)

Other Identifiers

03CHUS/FSH03

Identifier Type: -

Identifier Source: org_study_id