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InfertilityPhase 3NCT00335894

Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).

A Phase 3 study testing hMG-IBSA in people with Infertility, run by IBSA Institut Biochimique SA at 2 sites in Italy.

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

Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and the other the reference drug hMG (Menopur, Ferring Pharmaceuticals, Inc.). Read more about this study

Who is it for?
Ages 18 to 36 years, women only
Conditions the study is for
Infertility
What is being tested?
hMG-IBSA
How many people
144 participants
Where
2 sitesItaly
Study dates
May 2005to Mar 2009
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 36 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women undergoing ovarian stimulation for IVF with or without ICSI (intracytoplasmic sperm injection) and with the following characteristics:
  • Voluntary given informed consent to study participation in writing encompassing consent to data recording and verification procedures;
  • > 18/= and < 37 years old;
  • BMI between 18 and 28 kg/m2;
  • Less than 3 previous completed IVF cycles;
  • Basal FSH level less than 10 IU/L once within 6 months prior to the study;
  • Within 12 month of the beginning of the study, uterine cavity consistent with expected normal function as assessed through a hysterosalpingogram, or sonohysterogram, or hysteroscopic examination or TVUS;
  • Normal or clinically insignificant haematology and blood chemistry values.

Who cannot join

  • Primary ovarian failure or women known as poor responders;
  • Signs of PCO, according to the Rotterdam Criteria;
  • At least one ovary inaccessible for oocyte retrieval;
  • One or more ovarian cysts > 10 mm;
  • Hydrosalpinx that have not been surgically removed or ligated;
  • Stage III or IV endometriosis;
Show all 17Show fewer
  • 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;
  • PAP smear III within the last 2 years;
  • Severe impairment of the renal and/or hepatic functions;
  • Lactation;
  • Hyperprolactinaemia;
  • Participation in a concurrent clinical trial or in another trial within the past four weeks;
  • Use of concomitant medication that might interfere with study evaluations.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Università degli Studi di Bologna

    Bologna, Bologna, 40138

  • Università degli Studi di Napoli Federico II

    Naples, Napoli, 80131

Other trials in Italy

About this study

Official title: A Prospective, Randomized, Investigator-blind, Controlled, Clinical Study of Phase III on the Efficacy and Tolerability of hMG-IBSA (IBSA) vs Menopur (Ferring) Administered s.c. in Women Undergoing COH in an ART Programme (IVF)

Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and the other the reference drug hMG (Menopur, Ferring Pharmaceuticals, Inc.).

Read the detailed description

The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous hMG preparations (hMG-IBSA, IBSA vs Menopur, Ferring Pharmaceuticals, Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.

Conditions
Infertility
Being tested
hMG-IBSA
Keywords
Infertility, IVF, ART, hMG
Medical subject headings
Infertility

What participants receive

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

  • hMG-IBSADrug

What is being measured

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

  1. total number of oocytes retrieved 34 - 36 hours after hCG administration.

Secondary outcomes (4)

  1. Total dose of hMG (IU); number of days of hMG stimulation and stimulation duration; cancellation rate with reasons; 17β-estradiol (E2) serum concentration; number of follicles >16 mm.

  2. number of mature oocytes and inseminated oocytes; fertilization rate.

  3. embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate

  4. Tolerability evaluation

Timeline

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

  1. First posted12 Jun 2006 (estimated)
  2. Study startMay 2005
  3. Primary completionMay 2008
  4. Study completionMar 2009

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
Single blind
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00335894
Sponsor's protocol ID
04I/HMG10
Status last verified
Dec 2008
First submitted
9 Jun 2006
Last updated
10 Mar 2010
Results posted
No

Publications

  • Hauschke D, Kieser M, Diletti E, Burke M. Sample size determination for proving equivalence based on the ratio of two means for normally distributed data. Stat Med. 1999 Jan 15;18(1):93-105. doi: 10.1002/(sici)1097-0258(19990115)18:13.0.co;2-8.

    PubMed 9990695

  • Veeck LL. Oocyte assessment and biological performance. Ann N Y Acad Sci. 1988;541:259-74. doi: 10.1111/j.1749-6632.1988.tb22263.x. No abstract available.

    PubMed 3195909

  • GEMZELL CA, DICZFALUSY E, TILLINGER G. Clinical effect of human pituitary follicle-stimulating hormone (FSH). J Clin Endocrinol Metab. 1958 Dec;18(12):1333-48. doi: 10.1210/jcem-18-12-1333. No abstract available.

    PubMed 13611018

  • Filicori M, Cognigni GE, Pocognoli P, Tabarelli C, Ferlini F, Perri T, Parmegiani L. Comparison of controlled ovarian stimulation with human menopausal gonadotropin or recombinant follicle-stimulating hormone. Fertil Steril. 2003 Aug;80(2):390-7. doi: 10.1016/s0015-0282(03)00594-6.

    PubMed 12909504

  • Kilani Z, Dakkak A, Ghunaim S, Cognigni GE, Tabarelli C, Parmegiani L, Filicori M. A prospective, randomized, controlled trial comparing highly purified hMG with recombinant FSH in women undergoing ICSI: ovarian response and clinical outcomes. Hum Reprod. 2003 Jun;18(6):1194-9. doi: 10.1093/humrep/deg252.

    PubMed 12773445

  • Thompson CR, Hansen LM. Pergonal (menotropins): a summary of clinical experience in the induction of ovulation and pregnancy. Fertil Steril. 1970 Dec;21(12):844-53. doi: 10.1016/s0015-0282(16)37925-0. No abstract available.

    PubMed 5481991

  • Oelsner G, Serr DM, Mashiach S, Blankstein J, Snyder M, Lunenfeld B. The study of induction of ovulation with menotropins: analysis of results of 1897 treatment cycles. Fertil Steril. 1978 Nov;30(5):538-44. doi: 10.1016/s0015-0282(16)43634-4. No abstract available.

    PubMed 720642

  • Schwartz M, Jewelewicz R, Dyrenfurth I, Tropper P, Vande Wiele RL. The use of human menopausal and chorionic gonadotropins for induction of ovulation. Sixteen years' experience at the Sloane Hospital for Women. Am J Obstet Gynecol. 1980 Dec 1;138(7 Pt 1):801-7. doi: 10.1016/s0002-9378(16)32740-5.

    PubMed 6778212

  • Notation AD, Tagatz GE, Steffes MW. Serum 17beta-estradiol. Index of follicular maturation during gonadotropin therapy. Obstet Gynecol. 1978 Feb;51(2):204-9.

    PubMed 622235

  • Mendelson EB, Bohm-Velez M, Joseph N, Neiman HL. Gynecologic imaging: comparison of transabdominal and transvaginal sonography. Radiology. 1988 Feb;166(2):321-4. doi: 10.1148/radiology.166.2.3275976.

    PubMed 3275976

  • Vermesh M, Kletzky OA. Follicle-stimulating hormone is the main determinant of follicular recruitment and development in ovulation induction with human menopausal gonadotropin. Am J Obstet Gynecol. 1987 Dec;157(6):1397-402. doi: 10.1016/s0002-9378(87)80231-4.

    PubMed 3122575

  • Brown JB, Evans JH, Adey FD, Taft HP, Townsend L. Factors involved in the induction of fertile ovulation with human gonadotrophins. J Obstet Gynaecol Br Commonw. 1969 Apr;76(4):289-307. doi: 10.1111/j.1471-0528.1969.tb05837.x. No abstract available.

    PubMed 5778792

  • Venturoli S, Paradisi R, Fabbri R, Magrini O, Porcu E, Flamigni C. Comparison between human urinary follicle-stimulating hormone and human menopausal gonadotropin treatment in polycystic ovary. Obstet Gynecol. 1984 Jan;63(1):6-11.

    PubMed 6419189

  • 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 hMG-IBSA in people with Infertility, run by IBSA Institut Biochimique SA at 2 sites in Italy.

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 17 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 10 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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?

total number of oocytes retrieved 34 - 36 hours after hCG administration.. 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 NCT00335894, which also lists 14 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 10 Mar 2010.

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