Clinical trial NCT01115725: A Study to Evaluate the Ease of Use, Local Tolerance, Safety and Effectiveness of Gonal-f® (Filled-by-mass in a Prefilled Pen)
Official title: Phase IV Study to Evaluate the Ease of Use, Local Tolerance Safety and Effectiveness of Gonal-f® (Filled-by-Mass in a Prefilled Pen)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Follitropin alfa
Fertilization in vitro
Intracytoplasmic sperm injection
Reproductive techniques, assisted
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: This is a prospective, open-label, non-comparative, multicentric Phase 4 study to evaluate the ease of use, local tolerance, safety and effectiveness of Gonal-f® (filled-by-mass in a prefilled pen) in subjects undergoing ovarian hyperstimulation for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with recombinant follicle stimulating hormone (r-FSH).

Clarification for change of study type:

The study was erroneously registered as an interventional trial on ClinicalTrials.gov between 2010 and 2012. It was shown recently that the study protocol and conduct of the study did not include any clinical interventions beyond those which are Standard Clinical Practice and the approved label for Gonal-f®. Furthermore, all other relevant study essential documentations (e.g. Informed Consent, CRF, etc.) are in line with an observational study design. As per EU regulations (Article 2(c) of Directive 2001/20/EC), this study is a 'non-interventional trial'.

Detailed description: Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as IVF and embryo transfer (ET) requires multiple follicular development to increase the number of female gametes, and the chances of a successful treatment outcome. Ovarian stimulation in IVF or ICSI currently includes suppression of endogenous luteinizing hormone (LH) secretion by administration of a gonadotropin releasing hormone (GnRH) agonist, followed by stimulation of multiple follicular development by exogenous FSH administration. When adequate follicular development is achieved, a single dose of u-hCG (urinary-human chorionic gonadotropin) is administered to mimic the endogenous LH surge and induce final oocyte maturation. Recombinant-human FSH (r-hFSH) has been shown to be superior to u-hFSH (urinary-derived FSH) in terms of requiring fewer ampoules and more efficacious in terms of number of oocytes recovered and in terms of pregnancy rates.

Recently, a new formulation of follitropin alfa has been developed as the next step in innovation in Serono capitalized on the fact that Serono recognized that follitropin alfa manufacturing was highly controlled and with a controlled specific activity that allowed filling the product by mass guaranteeing the dose being delivered. Until now follitropin alfa has been produced as a lyophilisate for injection (either as single dose or multidose applications) in glass ampoules or in glass vials and administered using syringes. Today, Gonal-f® fill-by-mass is available as a new liquid formulation that can be administered with the pen device which is prefilled and hence the subject does not have to assemble the device making it simpler to use.

OBJECTIVES

Primary objective:

To evaluate the ease-of-use of Gonal-f® (filled by mass in a prefilled pen) in subjects undergoing IVF/ICSI.

Secondary objectives:

To evaluate the local tolerance, safety and effectiveness of Gonal-f® prefilled pens.

Eligibility criteria: Inclusion Criteria:

* Pre-menopausal female subjects, between their 18th and 39th birthday
* Subjects with body mass index between 18-32 kilogram per square meter (kg/m\^2)
* Subjects with FSH (on second day of menstrual cycle) less than 10 milli international unit per milliliter (mIU/ml)
* Subjects who required treatment with recombinant FSH for controlled ovarian hyperstimulation for IVF and/or ICSI
* Subjects who are able to communicate well with the investigator and to comply with the requirements of the entire study
* Subjects who have given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice

Exclusion Criteria:

* Subjects who are not pregnant or lactating
* Subjects with known allergic reaction against one of the ingredients
* Subjects with enlarged ovaries or cysts unrelated to polycystic ovaries (PCO)
* Subjects with gynecological bleeding of unknown origin
* Subjects who have ovarian, uterine, or mammary cancer
* Subjects with hyperprolactinemia
* Subjects with tumors of the hypothalamus or the pituitary gland

Primary outcomes:
measure: Convenience assessment
timeFrame: Post-treatment assessment (35-42 days post embryo transfer)
Secondary outcomes:
measure: Efficacy assessments
timeFrame: Pre-study (within 3 months prior to study start) to days 35-42 post-hCG
measure: Safety and tolerance assessments
timeFrame: First stimulation day (S1) to days 15-20 post-hCG
Other outcomes:
Locations:
city: Athens
country: Greece
facility: EMBRYOGENESIS IVF Unit
state: Kifisias aV
Study officials:
affiliation: Merck A.E. Hellas, an affiliate of Merck KGaA, Darmstadt, Germany
name: Study Director
role: STUDY_DIRECTOR
References: