An Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to In-vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI)

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.

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Key information

Conditions

Multifollicular Stimulation Genital Diseases Infertility Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Maria Fertility Hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gonal-F (Follitropin alfa)

Drug

Follitropin alfa FbM solution for injection in a prefilled pen is available in three strengths: 300 IU/0.5 ml (22 µg/0.5 ml), 450 IU/0.75 ml (33 µg/0.75 ml) and 900 IU/1.5 ml (66 µg/1.5 ml). The starting dose is usually recommended to be between 150 and 300 IU. The dose is then adjusted according to the ovarian response.

Other names: Gonal-F

Primary outcomes

Efficacy

Time frame: Start of treatment to confirmation of pregnancy

Number of oocytes retrieved and clinical pregnancy rate per cycle

Secondary outcomes

Efficacy, Safety and Convenience

Time frame: Start of treatment to confirmation of pregnancy

Secondary efficacy parameters includes total Gonal-f dose; stimulation profile of IVF cycle; number of follicles > 14 mm on day of hCG; number of available embryos; pregnancy status (hCG test, ultrasound exam); on the day of embryo transfer (ET).

Convenience and safety parameters includes subject convenience rated by completing a questionnaire, local tolerance assessment (local reactions at the injection site, pain, satisfaction and convenience)

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

A Prospective, Multi-center, Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to IVF/ICSI

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Feb 25, 2010
Registry last updated: Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed