Infertility Clinical Trial
Official title:
A Phase IV, Prospective, Observational, Open Label, Single Centre Cohort Trial to be Conducted in Norway During One Year to Assess the Cumulative Pregnancy Rate in a New Series of In-vitro Fertilization (IVF) Treatment Cycles Following Three or More Previous IVF Treatment Cycles Without Live Birth.
Verified date | May 2014 |
Source | Merck KGaA |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Norwegian Medicines Agency |
Study type | Observational |
The primary objective of this observational study is to assess the cumulative rate of
ongoing pregnancy at 10 ±2 weeks after hCG administration in a new series of IVF-treatment
cycles in a total of 176 subjects, who have undergone three or more previous IVF-treatment
cycles without live birth. Secondary objectives include subgroup analysis on the effect of
age on the likelihood of pregnancy at 10 ±2 weeks after hCG administration in a new series
of IVF-treatment cycles in patients < 35 years and ≥ 35 years, who have undergone three or
more previous IVF-treatment cycles without live birth.
The information obtained from this trial will be helpful for subjects who are considering
further IVF treatments and for IVF centres, as well as for the formulation of governmental
policies regarding healthcare reimbursement in Norway.
Status | Completed |
Enrollment | 166 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility |
Inclusion Criteria: - Infertility justifying IVF/ET treatment - The decision of treating subject with GONAL-f or Pergoveris or GONAL-f and Luveris is made before considering the subject for the trial. - Age between 18th and 42nd birthday at the screening visit. - Have undergone three or more previous IVF-treatment cycles that did not result in live birth. - Have good general health that allows IVF therapy - Have a male partner with semen analysis, performed within 12 months prior to screening, that was considered adequate to proceed with regular insemination or ICSI according to the centre's standard practice - At least one ovary present - Have given written informed consent Exclusion Criteria: - FSH > 12 IU/L - Body mass index (BMI) > 40 kg/m2 - Pre-treatment antral follicle count [follicles =2mm - <11mm]) < 4 - Previous IVF attempts with no follicle development. - Any contraindication for the use of GONAL-f or Pergoveris or Luveris (refer to SPC) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Norway | Klinikk Hausken | Haugesund |
Lead Sponsor | Collaborator |
---|---|
Merck KGaA | Merck Serono Norway |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative ongoing pregnancy rate within one year of starting the trial in the total trial population | Ongoing pregnancy is defined as the existence of at least one ultra-sonographically-confirmed gestational sac in the uterus, with foetal heart activity | 10 ± 2 weeks after hCG administration | No |
Secondary | Number of mature follicles of =18 mm in size | 7 days before hCG administration till the day of hCG administration i.e.day (-)7 - 0 | No | |
Secondary | Number of oocytes retrieved | Day 2 | No | |
Secondary | Fertilisation rate | Day 3 | No | |
Secondary | Positive pregnancy test per cycle and cumulatively | 16 days post hCG administration | No | |
Secondary | Cumulative clinical pregnancy rate within one year of starting the trial | 5 weeks ± 2 weeks after hCG administration | No | |
Secondary | Clinical pregnancy rate per first, second and third new IVF-cycle | 5 weeks ± 2 weeks after hCG administration | No | |
Secondary | Ongoing pregnancy rate per first, second and third new IVF-cycle | 10 weeks ± 2 weeks after hCG administration | No | |
Secondary | Cumulative live birth rate(if available) | Follow-up period of 1 year | No | |
Secondary | Cumulative ongoing pregnancy rate within one year of starting the trial in subjects aged < 35 years and = 35 years | Ongoing pregnancy is defined as the existence of at least one ultra-sonographically-confirmed gestational sac in the uterus, with foetal heart activity | 10 ± 2 weeks after hCG administration | No |
Secondary | Ongoing pregnancy rate per IVF-treatment cycle within one year of starting the trial in the total trial population and in subgroup analysis in subjects aged < 35 years and = 35 years | 10 ±2 weeks after hCG administration | No |
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