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Internet-based Sex counseling and chances on natural conception in couples with Idiopathic Subfertility: a randomized clinical trial

Internet-based Sex counseling and chances on natural conception in couples with Idiopathic Subfertility: a randomized clinical trial - CoSy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50500
Enrollment
1112
Registered
2016-01-28
Start date
2016-06-27
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infertility unfulfilled desire to have children

Interventions

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

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Somatic or psychological problems interfering with couples* ability to have intercourse

Design outcomes

Primary

MeasureTime frame
Primary outcome: ongoing pregnancy conceived naturally within six months after randomization.

Secondary

MeasureTime frame
Secondary outcomes: time-to-pregnancy, live birth rate, costs, sexual activity, wellbeing and sexual functioning.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)