Efficacy and Safety of Fertility Treatments and Fertility Preservation

May 26, 2023 updated by: Kenny Rodriguez-Wallberg, Karolinska Institutet

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden, 141 86
        • Recruiting
        • Reproductive Medicine, Karolinska University Hospital
        • Contact:
        • Sub-Investigator:
          • Birgit Borgström, MD PhD
        • Sub-Investigator:
          • Anneli Liljegren, MD PhD
        • Sub-Investigator:
          • Anna Marklund, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 56 years (Child, Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • infertile patients and patients who undergo fertility preservation

Exclusion Criteria:

  • Healthy individuals, fertile population

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fertility preservation performed
subgroup analysis by cause of infertility, clinical characteristics, biochemical markers
Procedure: fertility preservation, several methods
fertility preservation using assisted reproductive techniques or not
Other Names:
  • cryopreservation, surgery
Fertility preservation not performed
subgroup analysis by cause of infertility, clinical characteristics, biochemical markers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy and safety of fertility preservation - Long-term follow-up
Time Frame: 2028
Correlation between method of fertility preservation and pregnacy rate
2028

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome of fertility treatments i breast cancer patients
Time Frame: 5-20 years post diagnosis
Fertility treatment vs no fertility treatment i breastcancer patients: effect on survival
5-20 years post diagnosis
Clinical outcome of fertility treatments i breast cancer patients
Time Frame: 5-7 years post diagnosis
Fertility treatment vs no fertility treatment i breastcancer patients: effect on disease free survival
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
Correlation between clinical variables (age, BMI, oocyte level, administered gonadotropins, infertility) method of fertility preservation and Pregnancy rate
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.
hCG vs GnRH trigger on effect on number of cryopreserved embryos and oocytes
Observed outcomes in patients registered between 1995 and 2017. Follow up until end of 2018.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

Investigators

  • Study Chair: Dan Grandér, Prof, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

October 20, 2020

First Posted (Actual)

October 26, 2020

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KI-KRW-200909-201505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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