Clinical trial NCT04602962: Efficacy and Safety of Fertility Treatments and Fertility Preservation
Official title: Studies Aiming at Identifying Predictors for Fertility Treatments' Outcomes and to Evaluate the Efficacy and Safety of Fertility Preservation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Keywords: fertility preservation
fertility treatment
safety
efficacy
fertility outcomes
follow-up
cohort
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2020-10-26
Enrollment: 50000
Sex: ALL
Maximum age (years): 56
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort collected from the registers of the university hospitals of Sweden, each representing a health care region, from 1995 and ongoing. FP is included in the tax funded healthcare system and data is registered all over the country. Date is also compared with the Swedish tax registry.

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.

Eligibility criteria: Inclusion Criteria:

* infertile patients and patients who undergo fertility preservation

Exclusion Criteria:

* Healthy individuals, fertile population

Primary outcomes:
measure: Efficacy and safety of fertility preservation - Long-term follow-up
timeFrame: 2028
Secondary outcomes:
measure: Clinical outcome of fertility treatments i breast cancer patients
timeFrame: 5-20 years post diagnosis
measure: Clinical outcome of fertility treatments i breast cancer patients
timeFrame: 5-7 years post diagnosis
measure: Predictors of effictive fertility treatment
timeFrame: patient data collected from time of treatment, pregnancy rate until end of study
measure: Efficacy and safety of COS using GnRHa for fertility preservation in BC patients
timeFrame: Observed outcomes in patients registered between 1995 and 2017. Follow up until end of 2018.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Reproductive Medicine, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Dan Grandér, Prof
role: STUDY_CHAIR
References:
citation: Wikander I, Lundberg FE, Nilsson H, Borgstrom B, Rodriguez-Wallberg KA. A Prospective Study on Fertility Preservation in Prepubertal and Adolescent Girls Undergoing Hematological Stem Cell Transplantation. Front Oncol. 2021 Jun 30;11:692834. doi: 10.3389/fonc.2021.692834. eCollection 2021.