Medical Assisted Reproduction With Artificial Gametes in Women With Ovarian Failure: Treatment Characteristics and Their Trade-offs Determining Treatment Preference of Patients and Clinicians
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 400
- Primary Endpoint
- Relative importance of predefined treatment characteristics
Study Overview
Brief Summary
To gain insight by means of a discrete choice experiment questionnaire into characteristics of medically assisted reproduction (MAR) with artificial gametes (AGs) valued by couples confronted with ovarian failure and their physicians and the trade-offs they make between these treatment characteristics.
Detailed Description
Introduction 3-17% of heterosexual couples trying to conceive will be faced with fertility problems (Boivin et al, 2007). Of these couples 50% will be confronted with a female factor, which includes amongst others ovarian failure (WHO, 2000). Ovarian failure can occur pre-maturely (i.e. before the age of 40 years old, in 1% of women; Coulam, 1982; Coulam et al., 1986) or at a physiologically natural age of after 40 years but before reaching the limit of 44 years old at which modern women that still want children can rely on reimbursed medical assisted reproduction (MAR) in European countries, such as Belgium and the Netherlands.
Although some couples with ovarian failure will have attempted MAR without success, they will be left with IVF with donor ooyctes or embryo reception as only treatment option. These treatment options will not result in genetic parenthood for one or both of the partners.
Researchers are currently developing new forms of MAR that do not require patients to have functional gametes but rely on artificial gametes (AGs) developed by means of different techniques (Hendriks et al, submitted).
Reproductive medicine experts are starting to reflect on the need for minimal thresholds of effectiveness and safety to introduce these and other new forms of MAR into clinical practice (Harper et al, 2012; Schatten, 2002; Winston & Hardy, 2002). Research, however, showed that specific subgroups of infertile patients value other treatment characteristics besides safety and effectiveness, such as, for example, naturalness (Hendriks et al, 2014; De Groot et al, submitted; Lankreijer et al, in preparation). The perspectives of couples with ovarian failure on MAR with AGs has yet to be explored. Clinicians' perspectives on MAR with AGs - valuable because of their expertise and their direct involvement in possible future decision-making - has not been studied. A previous study showed that clinicians differ from patients in their evaluation of the importance of characteristics of fertility clinics (van Empel et al, 2011) and would be interesting to compare the perspective of patients and clinicians on MAR with AGs
Objective The aim is to gain insight into characteristics of MAR with AGs valued by couples confronted with ovarian failure and their physicians and the trade-offs they make between these treatment characteristics.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 44 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Heterosexual couples confronted with infertility due to ovarian failure between the age of 18 and 44 years old treated in the K.U.Leuven
Exclusion Criteria
- •Not meeting inclusion criteria
Outcomes
Primary Outcomes
Relative importance of predefined treatment characteristics
Time Frame: single time point
Secondary Outcomes
- Demographic and self-reported medical data that define the importance of the treatment characteristics(single time poin)
