Efficacy and Safety of Fertility Treatments and Fertility Preservation

NCT ID: NCT04602962

Last Updated: 2023-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Fertility preservation performed

subgroup analysis by cause of infertility, clinical characteristics, biochemical markers

fertility preservation, several methods

Intervention Type PROCEDURE

fertility preservation using assisted reproductive techniques or not

Fertility preservation not performed

subgroup analysis by cause of infertility, clinical characteristics, biochemical markers

No interventions assigned to this group

Interventions

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fertility preservation, several methods

fertility preservation using assisted reproductive techniques or not

Intervention Type PROCEDURE

Other Intervention Names

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cryopreservation, surgery

Eligibility Criteria

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Inclusion Criteria

* infertile patients and patients who undergo fertility preservation

Exclusion Criteria

* Healthy individuals, fertile population
Maximum Eligible Age

56 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Kenny Rodriguez-Wallberg

MD, PhD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Grandér, Prof

Role: STUDY_CHAIR

Karolinska Institutet

Locations

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Reproductive Medicine, Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Dan Grandér, Prof

Role: CONTACT

Susanne Gruber

Role: CONTACT

Facility Contacts

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Mats Hellström, RN

Role: primary

References

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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.

Reference Type DERIVED
PMID: 34277437 (View on PubMed)

Other Identifiers

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KI-KRW-200909-201505

Identifier Type: -

Identifier Source: org_study_id

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