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Efficacy and Safety of Fertility Treatments and Fertility Preservation

Studies Aiming at Identifying Predictors for Fertility Treatments' Outcomes and to Evaluate the Efficacy and Safety of Fertility Preservation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04602962
Enrollment
50000
Registered
2020-10-26
Start date
2009-09-30
Completion date
2030-12-31
Last updated
2023-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

fertility preservation, fertility treatment, safety, efficacy, fertility outcomes, follow-up, cohort

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.

Interventions

PROCEDUREfertility preservation, several methods

fertility preservation using assisted reproductive techniques or not

Sponsors

Karolinska University Hospital
CollaboratorOTHER
Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
No minimum to 56 Years
Healthy volunteers
No

Inclusion criteria

* infertile patients and patients who undergo fertility preservation

Exclusion criteria

* Healthy individuals, fertile population

Design outcomes

Primary

MeasureTime frameDescription
Efficacy and safety of fertility preservation - Long-term follow-up2028Correlation between method of fertility preservation and pregnacy rate

Secondary

MeasureTime frameDescription
Clinical outcome of fertility treatments i breast cancer patients5-20 years post diagnosisFertility treatment vs no fertility treatment i breastcancer patients: effect on survival
Predictors of effictive fertility treatmentpatient data collected from time of treatment, pregnancy rate until end of studyCorrelation between clinical variables (age, BMI, oocyte level, administered gonadotropins, infertility) method of fertility preservation and Pregnancy rate
Efficacy and safety of COS using GnRHa for fertility preservation in BC patientsObserved outcomes in patients registered between 1995 and 2017. Follow up until end of 2018.hCG vs GnRH trigger on effect on number of cryopreserved embryos and oocytes

Countries

Sweden

Contacts

Primary ContactDan Grandér, Prof
dan.grander@ki.se
Backup ContactSusanne Gruber
susanne.gruber@ki.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026