Clinical trial NCT01075854: An Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to In-vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI)
Official title: A Prospective, Multi-center, Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to IVF/ICSI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multifollicular Stimulation
Keywords: Gonal-F
Multifollicular stimulation
Pregnancy
Ovarian hyperstimulation
In vitro fertilization
Intracytoplasmic sperm injection
Infertility
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 1539
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female subjects who are prescribed Gonal-F FbM by their treating physician for their IVF/ICSI treatment cycle will be eligible for the study.

Brief summary: This is a prospective, observational study in women using Gonal-F filled-by-mass (FbM) in ovarian hyperstimulation as part of their in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment at infertility clinics in Korea. The purpose of this study is to assess Gonal-F FbM in a practical setting encompassing all subject groups and local practices.

Detailed description: Follicle stimulating hormone (FSH) is a complex hetero-dimeric glycoprotein used therapeutically to stimulate follicular development in the ovary. The technical advance of recombinant technology to manufacture FSH has resulted in a biochemically pure FSH preparation with high batch-to-batch consistency. The protein content can be reliably quantified in mass units by size exclusion high performance liquid chromatography. These developments have enabled recombinant human FSH follitropin alfa (Gonal-F) to be filled and released in vials on the basis of mass with a variability of only ±2%. In one study, the FbM batches appeared to deliver a more consistent therapeutic effect than the filled-by-bioassay batches. In another randomized trial, self-administration and subjects' satisfaction were significantly higher in the pen device group than the conventional syringe group. Local reactions at injection sites and pain were significantly higher in the conventional syringe group than in the pen device group. The authors concluded that the pen device of Gonal-F is safe, convenient, and less painful, with more subject satisfaction than the conventional syringe form.

This prospective, multicentric, observational study is planned in women using Gonal-F FbM in ovarian hyperstimulation as part of their IVF/ICSI treatment at infertility clinics in Korea. Subjects fulfilling the eligibility criteria shall be enrolled in a consecutive manner over a 9-month period (approximately 1500 subjects).

OBJECTIVES

Primary objective:

* To assess the effectiveness Gonal-F FbM

Secondary objectives:

* To assess the safety and subject convenience of Gonal-F FbM in a normal clinical practice over a period of 9 months

Eligibility criteria: Inclusion Criteria:

* Women who are prescribed Gonal-F FbM by their treating physician for their IVF/ICSI treatment cycle will be eligible for this study

Exclusion Criteria:

* Subjects who have hypersensitivity to follitropin alfa, FSH or to any of the excipients
* Subjects with tumors of the hypothalamus and pituitary gland
* Ovarian enlargement or cyst not due to polycystic ovarian disease
* Gynecological hemorrhages of unknown etiology
* Ovarian, uterine or mammary carcinoma
* Primary ovarian failure
* Malformations of sexual organs incompatible with pregnancy
* Fibroid tumors of the uterus incompatible with pregnancy

Primary outcomes:
measure: Efficacy
timeFrame: Start of treatment to confirmation of pregnancy
Secondary outcomes:
measure: Efficacy, Safety and Convenience
timeFrame: Start of treatment to confirmation of pregnancy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Maria Fertility Hospital
Study officials:
References: