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Clinical Trials/NCT02280681
NCT02280681Active, not recruitingNot Applicable

Medical Assisted Reproduction With Artificial Gametes in Women With Ovarian Failure: Treatment Characteristics and Their Trade-offs Determining Treatment Preference of Patients and Clinicians

Universitaire Ziekenhuizen KU Leuven0 sites400 target enrollmentStarted: October 2014Last updated:
Conditions

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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