Decisional Process in Male Fertility Preservation

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
• Overall Status: Completed
• CT.gov ID: NCT02411214
• Collaborator: (none)
• Enrollment: 348
• Duration (Months): 23

Study Details

Study Description

Brief Summary

The survey analyses how to improve the decision-making process for fertility preservation in the pediatric population based on

1. patient and parent feelings about fertility preservation counselling

2. influence of the emotional state of patients and parents on fertility preservation acceptance

3. support of medical staff and family The study revealed that attention to the fertility preservation pathways was important for the satisfaction of patient's and parent's expectations

Condition or Disease	Intervention/Treatment	Phase
Infertility; Quality of Life; Cancer	Other: survey

Detailed Description

Questionnaire survey via regular mail to an eligible population (boys and adolescents aged 0 to 18 years diagnosed with cancer at the Cliniques universitaires Saint Luc) between January 2005 and May 2013.

Three different questionnaires, for children (<12 years and 12-18 years) and parents respectively, established based on information from focus groups and subsequently reviewed by the institutional ethics board before being sent.

Study Design

• Study Type: Observational
• Actual Enrollment: 348 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Fertility Preservation in the Male Pediatric Population: a Patient and Parent Perspective of Factors Influencing the Decisional Process
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
<12 years children under 12 years diagnosed with cancer questionnaire survey	Other: survey; questionnaire survey sent by regular mail for 3 groups
12-18 years adolescents diagnosed with cancer questionnaire survey	Other: survey; questionnaire survey sent by regular mail for 3 groups
parents parents of children and adolescents diagnosed with cancer questionnaire survey	Other: survey; questionnaire survey sent by regular mail for 3 groups

Outcome Measures

Primary Outcome Measures

1. factors improving the decision-making process for fertility preservation [less than 1 year]

   factors improving the decision-making process for fertility preservation assessed by three specific questionnaires (parent, adolescent and children)

Secondary Outcome Measures

1. patient and parent feelings about fertility counseling [less than 1 year]

   patient and parent feelings about fertility counseling assessed by three specific questionnaires (parent, adolescent and children)

2. influence of the emotional state of parents and patients on fertility preservation acceptance [less than 1 year]

   influence of the emotional state of parents and patients on fertility preservation acceptance assessed by three specific questionnaires (parent, adolescent and children)

3. support of medical staff and family [less than 1 year]

   support of medical staff and family assessed by three specific questionnaires support of medical staff and family (parent, adolescent and children)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• prepubertal boys and adolescents diagnosed with cancer in a university hospital setting between january 2005 and may 2013

Exclusion Criteria:

• none

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wyns, Head of department gynecology-andrology, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT02411214
• Other Study ID Numbers: FP1
• First Posted: Apr 8, 2015
• Last Update Posted: Apr 8, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Apr 8, 2015