Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT02454556
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2015-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Gema Biotech S.A.
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ®).
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: