Efficacy and Safety of Fertility Treatments and Fertility Preservation

NCT04602962 | Recruiting DMC

• 1 other identifier: KI-KRW-200909-201505
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Efficacy and safety of fertility preservation - Long-term follow-up

  Correlation between method of fertility preservation and pregnacy rate

  2028

Secondary Outcomes (4)

• Clinical outcome of fertility treatments i breast cancer patients

  5-20 years post diagnosis

• Clinical outcome of fertility treatments i breast cancer patients

  5-7 years post diagnosis

• Predictors of effictive fertility treatment

  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

  Observed outcomes in patients registered between 1995 and 2017. Follow up until end of 2018.

Study Arms (2)

Fertility preservation performed

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

Procedure: fertility preservation, several methods

Fertility preservation not performed

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

Interventions

fertility preservation, several methods PROCEDURE

fertility preservation using assisted reproductive techniques or not

Also known as: cryopreservation, surgery

Fertility preservation performed

Eligibility Criteria

• Age: Up to 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• infertile patients and patients who undergo fertility preservation

You may not qualify if:

• Healthy individuals, fertile population

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Reproductive Medicine, Karolinska University Hospital

Stockholm, 141 86, Sweden

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Fertility Preservation; Cryopreservation; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Tissue and Organ Harvesting; Transplantation; Investigative Techniques; Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological

Study Officials

• Dan Grandér, Prof

  Karolinska Institutet

  STUDY CHAIR

Central Study Contacts

Dan Grandér, Prof

CONTACT

dan.grander@ki.se

Susanne Gruber

CONTACT

susanne.gruber@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: October 26, 2020
• Study Start: September 1, 2009
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)