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InfertilityPhase 3NCT02454556

A Randomized, Multicentre, Open Label, Evaluator Blinded Study to Evaluate Safety and Efficacy of Folitime® of Gemabiotech S.A., Versus Gonal-f ® of Merck Serono, in Patients With Infertility Undergoing ART

A Phase 3 study testing FOLITIME® and Gonal-F® in people with Infertility, run by Gema Biotech S.A. at 1 site in Argentina.

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

This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the original one (Gonal-f ®). Read more about this study

Who is it for?
Ages 18 to 37 years, women only
Conditions the study is for
Infertility
What is being tested?
FOLITIME® and Gonal-F®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteArgentina
Study dates
Apr 2015to Dec 2016
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 37 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 18 to 38 years of age
  • Indication for controlled ovarian stimulation and IVF or intracytoplasmic sperm injection (ICSI)
  • Regular menstrual cycles (25-35 days)
  • History of a maximum of two fresh cycle treatments in the present series of assisted reproductive technologies (ART) at the day of first screening (thawed cycles are not subject to that criteria)
  • Body mass index (BMI) ≥18 and ≤32 kg/m2
  • Basal FSH <10 IU/L (cycle day 2-5)
Show all 12Show fewer
  • Antral follicle count (AFC) ≥8 to ≤18 follicles with a diameter of <10mm (sum of both ovaries) as measured on ultrasound (US) in the early follicular phase (day 1 of the stimulation cycle or of the last cycle previous to the treatment)
  • Documented history of infertility due to any of the following factors: tubal factor, male factor, unexplained infertility
  • Presence of both ovaries by ultrasonography and normal uterine cavity or abnormal uterine cavity without clinical significance according to the investigator's opinion (confirmed by hysterosalpingography, saline infusion sonography or hysteroscopy within 12 months before randomization) and normal uterine cavity by transvaginal ultrasound within 3 months of treatment
  • Male partner with semen analysis that is at least adequate for ICSI within 6 months prior to patient beginning down-regulation (invasive or surgical sperm retrieval, donor and/or cryopreserved sperm may be used)
  • Willingness to participate in the study and to comply with the study protocol
  • Signed informed consent prior to screening

Who cannot join

  • Presence of pregnancy
  • History of or active polycystic ovary syndrome (PCOS)
  • AFC >18 follicles with a diameter of <10 mm (both ovaries combined) as measured on US in the early follicular phase (menstrual cycle day 2-5) or during
  • History of >2 unsuccessful fresh ART retrieval cycles
  • History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt)
  • Any hormonal treatment within 1 month before the start of the FSH treatment, with the exception of levothyroxine)
Show all 20Show fewer
  • Egg donor
  • Intrauterine leiomyomas ≥5 cm or otherwise clinically relevant pathology that could impair embryo implantation or pregnancy continuation
  • Previous history of OHSS
  • Ovarian cyst or enlargement of undetermined origin
  • History of recurrent spontaneous abortion (3 or more, even when unexplained)
  • Presence of endometriosis or hydrosalpinx
  • Neoplasia, including tumors of the hypothalamus and pituitary gland
  • Abnormal genital bleeding of undetermined origin
  • History of extrauterine pregnancy in the previous 3 months
  • Sex hormone dependent tumors of the reproductive tract and accessory organs.
  • Uncontrolled thyroid or adrenal dysfunction or presence of uncontrolled endocrine disorder
  • Known allergy or hypersensitivity to FSH preparations or one of their excipients or progesterone or to any of the excipients of the additional study medications
  • Clinically significant abnormal findings at Visit 1 that, in the opinion of the investigator, can affect trial resulkts or subject's safety
  • Administration of other investigational products within the previous month or concomitant participation in another study protocol

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Halitus Instituto Médico

    Buenos Aires, Buenos Aires F.D., C1122AAF

Other trials in Argentina

About this study

This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the original one (Gonal-f ®).

Read the detailed description

Follitropin alfa is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, nonidentical glycoproteins designated as the alfa- and beta-subunits. Similar to other glycoprotein hormones, FSH has a high degree of heterogeneity due to differences in the amount and/or composition of the carbohydrate residues, particularly sialic acid. FSH, the active component of r-hFSH is the most important hormone responsible for follicular recruitment and development. In order to obtain final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following the administration of r-hFSH when monitoring of the patient indicates that sufficient follicular development has occurred.

Secondary endpoints to be measured by the study are

Efficacy

  • Total dose of r-hFSH required,
  • Number of days of r-hFSH stimulation
  • Percentage of patients with need to increase or lower the dose of r-hFSH,
  • Number of treatment cycle cancellations and their reason
  • Fertilization rate
  • Number of fertilized oocytes
  • Number of good quality embryos
  • Number of embryos transferred
  • Implantation Rate
  • Biochemical pregnancy
  • Clinical pregnancy 10 weeks post embryo transfer
  • Pregnancy outcome

Safety

Incidence of

  • OHSS (and its severity)
  • Local reactions (pain, bruising, redness, itching, swelling)
  • Systemic drug adverse events

Tolerability

  • Frequency of patients who withdraw the study drug due to lack of tolerance
  • Frequency of patients who withdraw the study drug treatment due to any reason
  • Patient Reported Pain: measured by a Patients Visual Analog Scale (VAS)

Immunogenicity Measurement of possible antibodies against exogenous r-hFSH will be evaluated. Pharmacodynamics

  • Number and size distribution of follicles during treatment
  • Number and size distribution of follicles at the day of ovulation induction (uHCG)
  • Number of follicles >14 mm on the day of hCG injection.
  • Hormone parameters: serum levels of estradiol, luteinizing hormone and progesterone on the day of hCG injection
  • Metaphase II oocytes;
  • Number of good quality oocytes
Conditions
Infertility
Being tested
FOLITIME®, Gonal-F®
Keywords
Assisted reproduction technologies, Follicle stimulating hormone (FSH).
Medical subject headings
Infertility

What participants receive

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

  • FOLITIME®Drug

    Also called Follitropin alfa (r-hFSH)

  • Gonal-F®Drug

    Also called Follitropin alfa (r-hFSH)

Study groups in NCT02454556
Study groupRoleWhat they receive
FOLITIME®ExperimentalTherapy will be initiated in the early follicular phase (cycle day 2 or 3) subcutaneously at a dose of 225 IU per day, until sufficient follicular development is attained.
Receives: Drug: FOLITIME®
Gonal-F®Active comparatorTherapy will be initiated in the early follicular phase (cycle day 2 or 3) subcutaneously at a dose of 225 IU per day, until sufficient follicular development is attained.
Receives: Drug: Gonal-F®

What is being measured

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

  1. Number of oocytes retrieved

    Measured: 5 days

Timeline

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

  1. First posted27 May 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
Who is masked
Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02454556
Sponsor's protocol ID
GEMFOL001
Status last verified
Feb 2017
First submitted
22 May 2015
Last updated
24 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FOLITIME® and Gonal-F® in people with Infertility, run by Gema Biotech S.A. at 1 site in Argentina.

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 12 inclusion and 20 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. 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 retrieved (time frame: 5 days). 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 NCT02454556.

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 24 Feb 2017.

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