Efficacy and Safety of Fertility Treatments and Fertility Preservation

Study Overview
=================
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.

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

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: fertility preservation, several methods


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertile patients and patients who undergo fertility preservation Exclusion Criteria: Healthy individuals, fertile population

Ages Eligible for Study
-----------------
Maximum Age: 56 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fertility preservation performed<br>subgroup analysis by cause of infertility, clinical characteristics, biochemical markers | Procedure: fertility preservation, several methods<br>* fertility preservation using assisted reproductive techniques or not<br>* Other names: cryopreservation, surgery;|
| Fertility preservation not performed<br>subgroup analysis by cause of infertility, clinical characteristics, biochemical markers | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and safety of fertility preservation - Long-term follow-up | Correlation between method of fertility preservation and pregnacy rate | 2028 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fertility preservation, fertility treatment, safety, efficacy, fertility outcomes, follow-up, cohort