An Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to In-vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI)
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| ClinicalTrials.gov Identifier: NCT01075854 |
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Recruitment Status :
Completed
First Posted : February 25, 2010
Last Update Posted : July 31, 2014
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| Condition or disease | Intervention/treatment |
|---|---|
| Multifollicular Stimulation | Drug: Gonal-F (Follitropin alfa) |
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
| Study Type : | Observational |
| Actual Enrollment : | 1539 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | A Prospective, Multi-center, Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to IVF/ICSI |
| Study Start Date : | April 2009 |
| Actual Primary Completion Date : | March 2010 |
| Actual Study Completion Date : | March 2010 |
- 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.Other Name: Gonal-F
- Efficacy [ Time Frame: Start of treatment to confirmation of pregnancy ]Number of oocytes retrieved and clinical pregnancy rate per cycle
- 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)
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075854
| Korea, Republic of | |
| Maria Fertility Hospital | |
| Seoul, Korea, Republic of | |
| Responsible Party: | Head of Medical Department, Merck Serono Korea, an affiliate of Merck KGaA, Darmstadt, Germany |
| ClinicalTrials.gov Identifier: | NCT01075854 |
| Other Study ID Numbers: |
EMR 700623_507 |
| First Posted: | February 25, 2010 Key Record Dates |
| Last Update Posted: | July 31, 2014 |
| Last Verified: | September 2010 |
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Gonal-F Multifollicular stimulation Pregnancy Ovarian hyperstimulation |
In vitro fertilization Intracytoplasmic sperm injection Infertility |
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Follicle Stimulating Hormone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |