NCT02454556

Brief 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 ®).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

May 22, 2015

Last Update Submit

February 23, 2017

Conditions

Infertility

Keywords

Assisted reproduction technologiesFollicle stimulating hormone (FSH).

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes retrieved

    5 days

Study Arms (2)

FOLITIME®

EXPERIMENTAL

Therapy 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.

Drug: FOLITIME®

Gonal-F®

ACTIVE COMPARATOR

Therapy 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.

Drug: Gonal-F®

Interventions

FOLITIME®DRUG
Also known as: Follitropin alfa (r-hFSH)
FOLITIME®
Gonal-F®DRUG
Also known as: Follitropin alfa (r-hFSH)
Gonal-F®

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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)
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halitus Instituto Médico

Buenos Aires, Buenos Aires F.D., C1122AAF, Argentina

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Sergio Pasqualini, MD

    Halitus Instituto Medico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2015

First Posted

May 27, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

AR(1)