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

NCT00378001 | Completed Phase 3

• 1 other identifier: 03CHUS/FSH03
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 4

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.

Conditions

Infertility

Keywords

Infertility, FSH, IVF, Ovarian stimulation

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the total number of oocytes retrieved.

Secondary Outcomes (4)

• Total FSH dose (IUs);number of days of FSH stimulation and stimulation duration;number of follicles >14 mm on the day of hCG injection;

• 17-β estradiol (E2) serum concentration on the day of hCG injection;cancellation rate with reasons;

• Fertilization rate: number of 2PN (or already cleaved) embryos;

• 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.

Interventions

FSH-IBSA DRUG

GONAL-F DRUG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \>/=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.

You may not qualify if:

• · 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;

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (4)

Fertility Physicians of Northern California

Palo Alto, California, 94301, United States

Location

San Diego Fertility Center

San Diego, California, 92130, United States

Location

UCSF In Vitro Fertilization

San Francisco, California, 94115-0916, United States

Location

Seattle Reproductive Medicine

Seattle, Washington, 98109, United States

Location

Related Publications (10)

• Templeton A, Morris JK. Reducing the risk of multiple births by transfer of two embryos after in vitro fertilization. N Engl J Med. 1998 Aug 27;339(9):573-7. doi: 10.1056/NEJM199808273390901.

  PMID: 9718375 BACKGROUND

• 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.

  PMID: 6150318 BACKGROUND

• 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.

  PMID: 2193939 BACKGROUND

• Hughes EG, Fedorkow DM, Daya S, Sagle MA, Van de Koppel P, Collins JA. The routine use of gonadotropin-releasing hormone agonists prior to in vitro fertilization and gamete intrafallopian transfer: a meta-analysis of randomized controlled trials. Fertil Steril. 1992 Nov;58(5):888-96. doi: 10.1016/s0015-0282(16)55430-2.

  PMID: 1426372 BACKGROUND

• 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.

  PMID: 3114314 BACKGROUND

• 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.

  PMID: 7714147 BACKGROUND

• 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.

  PMID: 8006130 BACKGROUND

• 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.

  PMID: 7989500 BACKGROUND

• 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.

  PMID: 7615113 BACKGROUND

• 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.

  PMID: 2660037 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Valerie Baker, MD

  Fertility Physicians of Northern California

  PRINCIPAL INVESTIGATOR

• Victor Y Fujimoto, MD

  UCSF In Vitro Fertilization

  PRINCIPAL INVESTIGATOR

• L. Michael Kettel, MD

  San Diego Fertility Center

  PRINCIPAL INVESTIGATOR

• Michael R Soules, MD

  Seattle Reproductive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 15, 2006
• First Posted: September 19, 2006
• Study Start: March 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: February 16, 2015

Record last verified: 2015-02

Locations

US (4)