AzTrials
AzTrials

InfertilityPhase 3NCT00378001

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

A Phase 3 study testing FSH-IBSA and GONAL-F in people with Infertility, run by IBSA Institut Biochimique SA at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Infertility
What is being tested?
FSH-IBSA and GONAL-F
How many people
152 participants
Where
4 sitesUnited States
Study dates
Mar 2005to May 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • >/=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.

Who cannot join

  • · 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;
Show all 16Show fewer
  • 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).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Fertility Physicians of Northern California

    Palo Alto, California, 94301

  • San Diego Fertility Center

    San Diego, California, 92130

  • UCSF In Vitro Fertilization

    San Francisco, California, 94115-0916

  • Seattle Reproductive Medicine

    Seattle, Washington, 98109

Other trials in United States

About this study

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.

Read the 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
Being tested
FSH-IBSA, GONAL-F
Keywords
Infertility, FSH, IVF, Ovarian stimulation
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FSH-IBSADrug

  • GONAL-FDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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

  2. 17-β estradiol (E2) serum concentration on the day of hCG injection;cancellation rate with reasons;

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

  4. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2006 (estimated)
  2. Study startMar 2005
  3. Primary completionMay 2006
  4. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
152 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00378001
Sponsor's protocol ID
03CHUS/FSH03
Status last verified
Feb 2015
First submitted
15 Sep 2006
Last updated
16 Feb 2015
Results posted
No

Publications

  • 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.

    PubMed 9718375

  • 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.

    PubMed 6150318

  • 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.

    PubMed 2193939

  • 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.

    PubMed 1426372

  • 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.

    PubMed 3114314

  • 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.

    PubMed 7714147

  • 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.

    PubMed 8006130

  • 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.

    PubMed 7989500

  • 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.

    PubMed 7615113

  • 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.

    PubMed 2660037

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FSH-IBSA and GONAL-F in people with Infertility, run by IBSA Institut Biochimique SA at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint is the total number of oocytes retrieved.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00378001, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.

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