To evaluate the course of psychological emotions, from the active treatment period until the first pregnancy test result, in IVF patients participating in a randomized controlled trial comparing two different IVF treatments (ENDO-RECEPT).
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The differences in course of psychological emotions, e.g. different elevated
levels of anxiety or different levels of anxiety at different time points
during two different IVF treatments, especially at oocyte retrieval and
pregnancy testing.
Secondary outcome
The secondary outcome is stress in relation to pregnancy outcome.
Background summary
In vitro fertilization (IVF) treatments are psychologically and emotionally
stressful. Little research has been carried out to document the psychological
processes that unfold during IVF treatments. Most randomized clinical
randomized trials are focused on the primary medical outcome. The aim of the
present study is to document the course of psychological emotions like anxiety,
depression, positive affect and coping from the start of the ovarian stimulated
period up to the first pregnancy test result in two different fertility
treatments. Daily emotional reactions (e.g., anxiety, depression and positive
affect) and coping during active treatment, and the waiting time up to whether
pregnancy was achieved will be monitored using a daily record-keeping checklist
designed for fertility treatment.
Study objective
To evaluate the course of psychological emotions, from the active treatment
period until the first pregnancy test result, in IVF patients participating in
a randomized controlled trial comparing two different IVF treatments
(ENDO-RECEPT).
Study design
This study is a prospective cohort study.
Daily emotions (i.e. anxiety, depression and positive affect) will be
documented during the active phase of the fertility treatment using daily
record keeping checklists. These checklists are designed specifically for
patients undergoing fertility treatments. In addition, we will measure the
cortisol levels from saliva samples at four different time points during the
treatment.
Study burden and risks
The burden of participation equals the filling out of a short daily record
keeping checklist during either seven or eleven weeks depending on the
allocation for treatment and five mornings of saliva sampling. Participation to
this study has no increased risks for the couples undergoing in vitro
fertilization treatment. The benefit to the couple is the expected increased
insight in the experienced distress during in vitro fertilization treatments.
Healthcare professionals can assist their patients by facilitating coping
strategies that better fit the demands of the IVF/ICSI treatment and by
offering support once outcomes are known.
meibergdreef 9
Amsterdam 1105AZ
NL
meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
All patients that are participating in the ENDO-RECEPT trial
Exclusion criteria
Patients that are not willing to sign the informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44651.000.13 |