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InfertilityPhase 3NCT00464607

Prospective, Randomized, Controlled, Clinical Study on Tolerability and Efficacy of hMG-IBSA

A Phase 3 study testing hMG-IBSA and Ovarian stimulation in people with Infertility, run by IBSA Institut Biochimique SA at 4 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

Purpose of the study is the evaluation of the tolerability (both local and systemic) and the clinical efficacy (in terms oocytes recovered) of subcutaneously versus intramuscularly administered Merional® (IBSA, Lugano - CH) in patients undergoing controlled ovarian hyperstimulation (COH) in an ART programme (IVF). Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
Infertility
What is being tested?
hMG-IBSA and Ovarian stimulation
Type of treatment
Surgery or procedure
How many people
160 participants
Where
4 sitesItaly
Study dates
Dec 2001to Apr 2005
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 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female patients
  • aged between 20 and 40 years
  • undergoing ovarian stimulation for the purposes of oocyte retrieval in an assisted conception programme
  • Body Mass Index (BMI) 20-28 kg/m2
  • early follicular phase FSH level < 9 IU/l.

Who cannot join

  • ascertained or presumptive hypersensitivity to the active principle and/or their ingredients
  • primary ovarian failure
  • ovarian cysts or enlargement not due to polycystic ovarian syndrome
  • oocyte donation
  • abnormal bleeding of undetermined origin
  • patients who have exhibited poor response or requiring doses of more than 300 IU daily in previous treatment cycles or those who have received similar therapies (previous treatment cycles) in the 30 days prior to the beginning of the present study
Show all 14Show fewer
  • uncontrolled thyroid or adrenal dysfunction
  • neoplasia
  • severe impairment of the renal and/or hepatic functions
  • diabetes and active thrombophlebitis, cardiopathies and epilepsy
  • presence of clinically significant systemic disease or any contraindication of being pregnant and/or carrying out a pregnancy to term
  • presence of any anatomical abnormality of the reproductive system
  • being pregnant or breastfeeding
  • menopause

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Ospedale S. Martino

    Genova, Genova, 16132

  • Ospedale S. Paolo

    Milan, Milano, 20142

  • Ospedale Federico II

    Naples, Napoli, 80131

  • Ospedale S. Anna

    Torino, Torino, 10126

Other trials in Italy

About this study

Official title: A Prospective, Randomized, Controlled Clinical Study on the Assessment of Tolerability and of Clinical Efficacy of MERIONAL® (hMG-IBSA) Administered Subcutaneously Versus MERIONALâ Administered Intramuscularly in Women Undergoing Controlled Ovarian Hyperstimulation (COH) in an ART Programme (IVF)

Purpose of the study is the evaluation of the tolerability (both local and systemic) and the clinical efficacy (in terms oocytes recovered) of subcutaneously versus intramuscularly administered Merional® (IBSA, Lugano - CH) in patients undergoing controlled ovarian hyperstimulation (COH) in an ART programme (IVF).

Conditions
Infertility
Being tested
hMG-IBSA, 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.

  • hMG-IBSADrug

  • Ovarian stimulationProcedure or surgery

What is being measured

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

  1. Number of oocytes recovered

Secondary outcomes (2)

  1. Efficacy: Day of Oocyte collection, 17β-estradiol Cmax, Total dose of gonadotrophin (IU) or n° of vials and n° of vials/day,Number of mature follicles (follicles ³ 16 mm in diameter) on hCG day (or one day earlier), Clinical pregnancy rate

  2. Tolerability: Number of Adverse Events (AEs) experienced during the study, Occurrence of Ovarian Hypestimulation Syndrome (OHSS), Local tolerability at the injection site, Haematological-biochemical laboratory tests, before and after treatment,

Timeline

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

  1. First posted23 Apr 2007 (estimated)
  2. Study startDec 2001
  3. Study completionApr 2005

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
None (open label)
Enrolment
160 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00464607
Sponsor's protocol ID
00IF/HMG06
Status last verified
Apr 2007
First submitted
20 Apr 2007
Last updated
23 Apr 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing hMG-IBSA and Ovarian stimulation in people with Infertility, run by IBSA Institut Biochimique SA at 4 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 5 inclusion and 14 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 23 Apr 2007. 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 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?

Number of oocytes recovered. 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 NCT00464607.

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 23 Apr 2007.

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