Efficacy and Safety of Fertility Treatments and Fertility Preservation

Recruiting

• Conditions: Infertility

• Registration Number: NCT04602962
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-26
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30
• Primary Completion: 2028-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50000

Inclusion Criteria

• infertile patients and patients who undergo fertility preservation

Exclusion Criteria

• Healthy individuals, fertile population

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy and safety of fertility preservation - Long-term follow-up	2028	Correlation between method of fertility preservation and pregnacy rate

Secondary Outcome Measures

Name	Time	Method
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.	hCG vs GnRH trigger on effect on number of cryopreserved embryos and oocytes
Clinical outcome of fertility treatments i breast cancer patients	5-7 years post diagnosis	Fertility treatment vs no fertility treatment i breastcancer patients: effect on disease free survival
Predictors of effictive fertility treatment	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

Trial Locations

Locations (1)

Reproductive Medicine, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden