Studies Aiming at Identifying Predictors for Fertility Treatments' Outcomes and to Evaluate the Efficacy and Safety of Fertility Preservation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Karolinska Institutet
- Enrollment
- 50000
- Locations
- 1
- Primary Endpoint
- Efficacy and safety of fertility preservation - Long-term follow-up
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study analyses clinical data prospectively collected for over a decade in several clinical databases. Electronic medical records are available since 1998.
Since 2011 the subgroup of patients that undergo fertility preservation are invited to participate in a prospective study aiming at long-term follow-up after fertility preservation for oncologic and non-oncologic conditions.
Detailed Description
In this study, the investigators aim at analyze the treatment outcomes of patients with infertility, their clinical characteristics and biochemical parameters aiming at identifying predictors for the treatment outcomes. For the cohort of patients that have undergone fertility preservation at Karolinska University Hospital, the investigators aim at investigating efficacy and safety of the procedures. The data can be expanded by using additional databases such as the Regional Cancer Registry and other registries. Analysis of data collected will allow the investigation of efficacy and safety of fertility preservation, identification of predictors for fertility outcomes,prediction of future activities and costs of the procedures.
Investigators
Kenny Rodriguez-Wallberg
MD, PhD, Associate Professor
Karolinska Institutet
Eligibility Criteria
Inclusion Criteria
- •infertile patients and patients who undergo fertility preservation
Exclusion Criteria
- •Healthy individuals, fertile population
Outcomes
Primary Outcomes
Efficacy and safety of fertility preservation - Long-term follow-up
Time Frame: 2028
Correlation between method of fertility preservation and pregnacy rate
Secondary Outcomes
- Efficacy and safety of COS using GnRHa for fertility preservation in BC patients(Observed outcomes in patients registered between 1995 and 2017. Follow up until end of 2018.)
- Clinical outcome of fertility treatments i breast cancer patients(5-7 years post diagnosis)
- Predictors of effictive fertility treatment(patient data collected from time of treatment, pregnancy rate until end of study)