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Efficacy and Safety of Fertility Treatments and Fertility Preservation

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ClinicalTrials.gov Identifier: NCT04602962
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : October 26, 2020
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Kenny Rodriguez-Wallberg, Karolinska Institutet

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.


Condition or disease Intervention/treatment
Infertility Procedure: fertility preservation, several methods

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.

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Study Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Studies Aiming at Identifying Predictors for Fertility Treatments' Outcomes and to Evaluate the Efficacy and Safety of Fertility Preservation
Actual Study Start Date : September 2009
Estimated Primary Completion Date : December 2028
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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 Name: cryopreservation, surgery

Fertility preservation not performed
subgroup analysis by cause of infertility, clinical characteristics, biochemical markers



Primary Outcome Measures :
  1. Efficacy and safety of fertility preservation - Long-term follow-up [ Time Frame: 2028 ]
    Correlation between method of fertility preservation and pregnacy rate


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 56 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • infertile patients and patients who undergo fertility preservation

Exclusion Criteria:

  • Healthy individuals, fertile population

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602962


Contacts
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Contact: Dan Grandér, Prof dan.grander@ki.se
Contact: Susanne Gruber susanne.gruber@ki.se

Locations
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Sweden
Reproductive Medicine, Karolinska University Hospital Recruiting
Stockholm, Sweden, 141 86
Contact: Mats Hellström, RN       mats.hellstrom@karolinska.se   
Sub-Investigator: Birgit Borgström, MD PhD         
Sub-Investigator: Anneli Liljegren, MD PhD         
Sub-Investigator: Anna Marklund, MD         
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Investigators
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Study Chair: Dan Grandér, Prof Karolinska Institutet
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Responsible Party: Kenny Rodriguez-Wallberg, MD, PhD, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04602962    
Other Study ID Numbers: KI-KRW-200909-201505
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kenny Rodriguez-Wallberg, Karolinska Institutet:
fertility preservation
fertility treatment
safety
efficacy
fertility outcomes
follow-up
cohort
Additional relevant MeSH terms:
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Infertility