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Recruiting NCT04602962

Efficacy and Safety of Fertility Treatments and Fertility Preservation

Observational Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fertility preservation, several methods.
Who it may be relevant to
Registry conditions: Infertility. Basic parameters: up to 56 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure fertility preservation, several methods
    fertility preservation using assisted reproductive techniques or not

Primary outcome measures

  • Efficacy and safety of fertility preservation - Long-term follow-up [Time frame: 2028]
Secondary outcome measures (4)
  • Clinical outcome of fertility treatments i breast cancer patients [Time frame: 5-20 years post diagnosis]
  • Clinical outcome of fertility treatments i breast cancer patients [Time frame: 5-7 years post diagnosis]
  • Predictors of effictive fertility treatment [Time frame: patient data collected from time of treatment, pregnancy rate until end of study]
  • Efficacy and safety of COS using GnRHa for fertility preservation in BC patients [Time frame: Observed outcomes in patients registered between 1995 and 2017. Follow up until end of 2018.]

Eligibility criteria

Inclusion criteria

  • infertile patients and patients who undergo fertility preservation

Exclusion criteria

  • Healthy individuals, fertile population

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Reproductive Medicine, Karolinska University Hospital — Stockholm

Publications

  • 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. PMID 34277437

Identifiers

NCT: NCT04602962 · KI-KRW-200909-201505

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗