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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Multifollicular Stimulation

Intervention / Treatment
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* Drug: Gonal-F (Follitropin alfa)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gonal-F (Follitropin alfa)|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Number of oocytes retrieved and clinical pregnancy rate per cycle | Start of treatment to confirmation of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy, Safety and Convenience | 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) | Start of treatment to confirmation of pregnancy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gonal-F, Multifollicular stimulation, Pregnancy, Ovarian hyperstimulation, In vitro fertilization, Intracytoplasmic sperm injection, Infertility