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van CCT (UK)

van CCT (UK)

De Zin en Zwanger studie

- candidate number23698
- NTR NumberNTR5709
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-feb-2016
- Secondary IDsZonMW 843001605  METC AMC (Amsterdam) NL55012.018.15
- Public TitleDe Zin en Zwanger studie
- Scientific Titlelntemet-based sex COunseling and chances on natural conception in couples with idiopathic SubfertilitY: a randomized clinical trial
- ACRONYMThe CoSy trial
- hypothesisOnline sex-counseling improves the probability of a naturally conceived pregnancy in heterosexual couples with unexplained subfertility and a good prognosis
- Healt Condition(s) or Problem(s) studiedUnexplained infertility
- Inclusion criteria1. Heterosexual couples with unexplained subfertility
2. ≥ 30% chance of an naturally conceived ongoing pregnancy calculated (Hunault)
3. Sufficient command of the Dutch language
- Exclusion criteria1. Somatic or psychological problems interfering with the couples ability to have sexual intercourse
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2016
- planned closingdate1-mrt-2019
- Target number of participants1164
- InterventionsSix months of internet-based sex counselling aiming to increase the probability of natural conception of an ongoing pregnancy
- Primary outcomeOngoing pregnancy, naturally conceived within six months after randomization
- Secondary outcome1. Time to pregnancy
2. Mean change in sexual activity
3. Mean change in each partnersí sexual functioning
4. Mean change in individual wellbeing of each partner
5. Time and interactive effects on all outcomes
- TimepointsOngoing pregnancy, naturally conceived within six months after randomization
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryEach year, 5,000 heterosexual couples are diagnosed with unexplained subfertility and a good prognosis (≥ 30% chance on a live-bornchild after natural conception within 12 months). The guidelines of the DutchSociety of Obstetrics and Gynaecology (NVOG) currently advise postponing medically assisted reproduction(MAR) for six months in these couples as this is equally effective as sixmonths of intra-uterine insemination (IUI) with controlled ovarian stimulation. Until now, expectant management simply means sending couples home for continuing to attempt natural conception without guidance on sexual activity,surveillance or support. Expectant management proves to be challenging in clinical practice because of pressure from desperate couples who have a lack of confidence in natural conception and who overestimate success rates of MAR.
According to a small cohort study, sex counselling can increase the proportion of couples having intercourse during their fertile days and can thereby increase ongoing pregnancy rates. Whether sex counselling indeed increases ongoing pregnancy rates, however, has never been demonstrated in a randomized clinical trial.

Objective To compare the effectiveness, expressed in terms of naturally conceived ongoing pregnancy rate, and the cost-effectiveness of six months of internet-based sex counseling to six months of expectant management without guidance on sexual activity, surveillance or support in couples with unexplained subfertility and a good prognosis.
- Main changes (audit trail)
- RECORD4-feb-2016 - 14-mei-2017

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