Efficacy and Safety of Fertility Treatments and Fertility Preservation

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04602962
• Other study ID #: KI-KRW-200909-201505
• Status: Recruiting
• Start date: September 2009
• Est. completion date: December 2030

Study information

• Verified date: May 2023
• Source: Karolinska Institutet
• Contact: Dan Grandér, Prof
• Email: dan.grander[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 2030
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 56 Years

Eligibility

Inclusion Criteria:

• infertile patients and patients who undergo fertility preservation

Exclusion Criteria:

• Healthy individuals, fertile population

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• fertility preservation, several methods
fertility preservation using assisted reproductive techniques or not

Locations

Country	Name	City	State
Sweden	Reproductive Medicine, Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy and safety of fertility preservation - Long-term follow-up	Correlation between method of fertility preservation and pregnacy rate	2028
Secondary	Clinical outcome of fertility treatments i breast cancer patients	Fertility treatment vs no fertility treatment i breastcancer patients: effect on survival	5-20 years post diagnosis
Secondary	Clinical outcome of fertility treatments i breast cancer patients	Fertility treatment vs no fertility treatment i breastcancer patients: effect on disease free survival	5-7 years post diagnosis
Secondary	Predictors of effictive fertility treatment	Correlation between clinical variables (age, BMI, oocyte level, administered gonadotropins, infertility) method of fertility preservation and Pregnancy rate	patient data collected from time of treatment, pregnancy rate until end of study
Secondary	Efficacy and safety of COS using GnRHa for fertility preservation in BC patients	hCG vs GnRH trigger on effect on number of cryopreserved embryos and oocytes	Observed outcomes in patients registered between 1995 and 2017. Follow up until end of 2018.