Objective of the study is to investigate whether couples with unexplained subfertility and a good prognosis have a significantly higher probability of naturally conceiving an ongoing pregnancy within six months if they are offered internet-based sex…
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: ongoing pregnancy conceived naturally within six months after
randomization.
Secondary outcome
Secondary outcomes: time-to-pregnancy, live birth rate, costs, sexual activity,
wellbeing and sexual functioning.
Background summary
The current policy with regard to unexplained infertile couples is six months
of expectant management in which couples are advised to attempt natural
conception without guidance on sexual activity, surveillance or support.
Research has shown that only 27% of these couples conceive within six months of
expectant management. Second, 67% of couples return for MAR after expectant
management and MAR. As MAR has many negative aspects, it is advised to prevent
this.
Study objective
Objective of the study is to investigate whether couples with unexplained
subfertility and a good prognosis have a significantly higher probability of
naturally conceiving an ongoing pregnancy within six months if they are offered
internet-based sex counseling than if they are offered expectant
management without guidance on sexual activity, surveillance or support.
Study design
INTERVENTION: Six months of internet-based sex counselling relying on sensate
focus, mindfulness, couple communication
skill training and education. This will be covered by eight progressive modules
including: information, exercises, a concluding
moderated group chat session and the unlimited opportunity to email with the
sexologist.
USUAL CARE/COMPARISON: Six months of expectant management in which couples are
advised to attempt natural
conception without guidance on sexual activity, surveillance or support.
OUTCOME MEASURES: Primary outcome: ongoing pregnancy conceived naturally within
six months after randomization.
Secondary outcomes: time-to-pregnancy, live birth rate, costs, sexual activity,
wellbeing and sexual functioning.
Intervention
INTERVENTION: Six months of internet-based sex counselling relying on sensate
focus, mindfulness, couple communication
skill training and education. This will be covered by eight progressive modules
including: information, exercises, a concluding
moderated group chat session and the unlimited opportunity to email with the
sexologist.
Study burden and risks
There are no extra risks associated with participating to this trial as
compared to couples who do not receive additional counseling.
The burden consists of participation in sex counseling. During the first three
months, both participants follow 1 module every two weeks, totalling to 6
modules. After that, two modules (one per month). The modules are provided
through an internet programme which is specifically designed for this study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1. Heterosexual couples
2. in which the woman is between 18 and 43 years of age
3. Unexplained subfertility (bilateral tubal patency, an ovulatory cycle and a
normal semen analysis)
4. At least 30% chance of an ongoing pregnancy after natural conception within
12 months, estimated based on female age, duration of subfertility, type of
subfertility (primary or secondary), percentage of progressively motile sperm,
and referral status (self-referral, secondary or tertiary care referral)
5. Sufficient command of the Dutch or English language
6. Willingness to give informed consent
Exclusion criteria
Somatic or psychological problems interfering with couples* ability to have
intercourse
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 | NL55012.018.15 |