Infertility Clinical Trial
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)
Verified date | December 2012 |
Source | Merck KGaA |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: National Organization of Medicines |
Study type | Observational |
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'.
Status | Completed |
Enrollment | 76 |
Est. completion date | July 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility |
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- Subjects who have given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice Exclusion Criteria: - Subjects who are not pregnant or lactating - Subjects with known allergic reaction against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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Greece | EMBRYOGENESIS IVF Unit | Athens | Kifisias aV |
Lead Sponsor | Collaborator |
---|---|
Merck KGaA |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Convenience assessment | Subjects' to complete ease questionnaire survey for use of Gonal-f prefilled pens. | Post-treatment assessment (35-42 days post embryo transfer) | No |
Secondary | Efficacy assessments | Secondary efficacy assessments include evaluation of the duration of stimulation; total amount of gonadotropins needed; number of follicles on the day of the last ultra-sound scan; estradiol (E2) on the day of the last ultra-sound scan; number of oocytes retrieved; number of oocytes fertilised; number of embryos transferred; clinical pregnancy by ultra-sound scan | Pre-study (within 3 months prior to study start) to days 35-42 post-hCG | No |
Secondary | Safety and tolerance assessments | Safety will be measured by the incidence and severity of adverse events (AEs) including local reactions; and incidence of ovarian hyperstimulation syndrome (OHSS) | First stimulation day (S1) to days 15-20 post-hCG | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03607409 -
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
|
||
Recruiting |
NCT02312076 -
GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
|
Phase 4 | |
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Completed |
NCT03287479 -
Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
|
N/A | |
Terminated |
NCT03522350 -
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
|
N/A | |
Completed |
NCT04496284 -
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
|
N/A | |
Completed |
NCT03623659 -
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
|
N/A | |
Completed |
NCT03895099 -
New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors
|
Phase 3 | |
Active, not recruiting |
NCT04142112 -
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
|
N/A | |
Completed |
NCT03152643 -
Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer
|
N/A | |
Recruiting |
NCT03683771 -
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
|
||
Recruiting |
NCT03161119 -
Comparing Two Different Embryo Transfer Catheters
|
N/A | |
Completed |
NCT04108039 -
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
|
N/A | |
Completed |
NCT03678610 -
Handling Medium for ICSI With Ionomycin and Latrunculin A
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A | |
Completed |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A | |
Completed |
NCT03678818 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A | |
Completed |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A |