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
NCT01071148 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 166
Last updated 2014-05-05
Summary
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.
Conditions
Sponsors & Collaborators
-
Merck Serono Norway
collaborator INDUSTRY -
Merck KGaA, Darmstadt, Germany
lead INDUSTRY
Principal Investigators
-
Viveka Åberg, MD · Merck Serono Norway
Eligibility
- Min Age
- 18 Years
- Max Age
- 42 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-06-30
- Primary Completion
- 2014-02-28
- Completion
- 2014-02-28
Countries
- Norway
Study Locations
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