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NCT Number: NCT04602962

Efficacy and Safety of Fertility Treatments and 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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

Up to 56 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Reproductive Medicine, Karolinska University Hospital

Stockholm, 141 86, Sweden

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • infertile patients and patients who undergo fertility preservation

Exclusion criteria

  • Healthy individuals, fertile population

Treatment and study plan

fertility preservation, several methods

Procedure

fertility preservation using assisted reproductive techniques or not

Other names: cryopreservation, surgery

Primary outcomes

  1. Efficacy and safety of fertility preservation - Long-term follow-up

    Time frame: 2028

    Correlation between method of fertility preservation and pregnacy rate

Secondary outcomes

  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

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2028
Study completion
2030
First posted
Oct 26, 2020
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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