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InfertilityPhase 3NCT00335569

Clinical Tolerance and Equivalence of hCG-IBSA vs Recombinant Human Chorionic Gonadotrophin in Women Undergoing In Vitro Fertilisation

A Phase 3 study testing hCG-IBSA in people with Infertility, run by IBSA Institut Biochimique SA at 4 sites in Switzerland.

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 equivalence and the general tolerability of two different subcutaneous hCG preparations (hCG-IBSA, IBSA vs Ovitrelle, Serono) when administered to patients undergoing 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?
hCG-IBSA
How many people
144 participants
Where
4 sitesSwitzerland
Study dates
Aug 2005to Dec 2008
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 previous completed cycles;
  • both ovaries present;
  • regular menstrual cycle of 25-35 days;
  • infertility attributable to a tubal factor, American Fertility Society grade I or II endometriosis, male factor or unexplained factor.
Show all 11Show fewer
  • within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through hysterosalpingogram, sonohystrogram or hysteroscopic examination;
  • basal FSH level less than 10 IU/L;
  • criteria for hCG administration fulfilled (at least 2 follicles with a diameter of 16 mm or more, with acceptable serum E2 concentration).
  • a male partner with semen analysis within the past 6 months showing acceptable values of seminal parameters, defined as > 3x10 exp 6 spermatozoa/ml;
  • qualified to receive 150 - 300 IU FSH as starting dose.

Who cannot join

  • age < 18 and > o = 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 < 3'000 pmol/L);
  • ovarian cysts > 20 mm, or enlargement not due to polycystic ovarian syndrome;
  • patients affected by pathologies associated with any contraindication of being pregnant;
  • hypersensitivity to the study medication;
  • any bleeding since stimulation;
Show all 11Show fewer
  • uncontrolled thyroid or adrenal dysfunction;
  • neoplasias;
  • severe impairment of the renal and/or hepatic functions;
  • use of concomitant medication that might interfere with study evaluations (e.g. nonstudy hormonal medications, prostaglandin inhibitors, psychotropic agents);
  • more than 18 days of FSH stimulation.

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites

  • Department of Gynecology and Obstetrics Universitätfrauenklinik

    Basel, 4031

  • 4. Department of Gynecology and Obstetrics Frauenklinik, InselspitalEffingerstrasse 102

    Bern, 3010

  • Department of Gynecology and ObstetricsUniversity Hospital

    Geneva, 1211

  • 3. Maternity CHUV - Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

Other trials in Switzerland

About this study

Official title: A Prospective, Randomized, Controlled Clinical Study on the Assessment of Tolerance and Clinical Equivalence of hCG- IBSA (IBSA) Versus Ovitrelle (Serono), Both Administered Sub-cutaneously in Women Undergoing in Vitro Fertilization (IVF).

The purpose of the study is to evaluate the clinical equivalence and the general tolerability of two different subcutaneous hCG preparations (hCG-IBSA, IBSA vs Ovitrelle, Serono) when administered to patients undergoing IVF.

Read the detailed description

This is a prospective, multicenter, randomized, investigator blind, parallel group, active control, phase III clinical trial. Patients meeting the eligibility requirements of the study will be randomly assigned to receive either the test drug (hCG-IBSA, IBSA) or the reference drug (Ovitrelle, Serono). 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
hCG-IBSA
Keywords
Infertility, sterility, hCG, IVF
Medical subject headings
Infertility

What participants receive

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

  • hCG-IBSADrug

What is being measured

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

  1. Total number of oocytes retrieved per patient who received hCG

Secondary outcomes (5)

  1. Number of patients who received hCG with at least one oocyte retrieved, 2PN fertilized oocytes,

  2. 2PN or cleaved embryos, implantation rate per embryo transferred; Serum P and hCG concentration on the days of oocyte retrieval, on day of embryo transfer and on day 5-8 post-hCG;

  3. Implantation rate;Pregnancy rate.

  4. Adverse Events

    Adverse events were monitored and collected during all the study period

    Measured: from day 1 to 35 +/- 7 days after oocytes retrieval

  5. Incidence of moderate or severe OHSS

    The incidence moderate or severe of OHSS will be assessed in both treatment groups

    Measured: From the day of hCG injection until 35 +/- 7 days after oocyte retrieval

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 startAug 2005
  3. Study completionDec 2008

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
NCT00335569
Sponsor's protocol ID
04CH/HCG02
Status last verified
May 2011
First submitted
9 Jun 2006
Last updated
1 Jun 2011
Results posted
No
Data monitoring committee
No

Publications

  • Pierce JG, Parsons TF. Glycoprotein hormones: structure and function. Annu Rev Biochem. 1981;50:465-95. doi: 10.1146/annurev.bi.50.070181.002341. No abstract available.

    PubMed 6267989

  • Johnsen SG. A study of human testicular function by the use of human menopausal gonadotrophin and of human chorionic gonadotrophin in male hypogonadotrophic eunuchoidism and infantilism. Acta Endocrinol (Copenh). 1966 Oct;53(2):315-41. doi: 10.1530/acta.0.0530315. No abstract available.

    PubMed 6012569

  • Forest MG, David M, Lecoq A, Jeune M, Bertrans J. Kinetics of the HCG-induced steroidogenic response of the human testis. III. Studies in children of the plasma levels of testosterone and HCG: rationale for testicular stimulation test. Pediatr Res. 1980 Jun;14(6):819-24. doi: 10.1203/00006450-198006000-00009.

    PubMed 6105640

  • GEMZELL C. INDUCTION OF OVULATION WITH HUMAN GONADOTROPINS. Recent Prog Horm Res. 1965;21:179-204. No abstract available.

    PubMed 14321057

  • Fleischer AC. Transabdominal and transvaginal sonography of ovarian masses. Clin Obstet Gynecol. 1991 Jun;34(2):433-42. doi: 10.1097/00003081-199106000-00027.

    PubMed 1868645

  • 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

  • Abdalla HI, Ah-Moye M, Brinsden P, Howe DL, Okonofua F, Craft I. The effect of the dose of human chorionic gonadotropin and the type of gonadotropin stimulation on oocyte recovery rates in an in vitro fertilization program. Fertil Steril. 1987 Dec;48(6):958-63. doi: 10.1016/s0015-0282(16)59591-0.

    PubMed 3119376

  • 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

  • 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

  • Bellavia M, de Geyter C, Streuli I, Ibecheole V, Birkhauser MH, Cometti BP, de Ziegler D. Randomized controlled trial comparing highly purified (HP-hCG) and recombinant hCG (r-hCG) for triggering ovulation in ART. Gynecol Endocrinol. 2013 Feb;29(2):93-7. doi: 10.3109/09513590.2012.730577. Epub 2012 Nov 2.

    PubMed 23116325

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing hCG-IBSA in people with Infertility, run by IBSA Institut Biochimique SA at 4 sites in Switzerland.

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 11 inclusion and 11 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 1 Jun 2011. 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 Switzerland. 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 per patient who received hCG. 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 NCT00335569, which also lists 12 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 1 Jun 2011.

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