Online sex-counseling improves the probability of a naturally conceived pregnancy in heterosexual couples with unexplained subfertility and a good prognosis
ID
Bron
Verkorte titel
Aandoening
1. Unexplained subfertility for at least one year
2. Chance on a spontaneous pregnancy of ≥ 30% calculated by the model of Hunault
3. An advice for expectant management for at least 6 months
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Ongoing pregnancy, naturally conceived within six months after randomization
Achtergrond van het onderzoek
Each 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.
Doel van het onderzoek
Online sex-counseling improves the probability of a naturally conceived pregnancy in heterosexual couples with unexplained subfertility and a good prognosis
Onderzoeksopzet
Ongoing pregnancy, naturally conceived within six months after randomization
Onderzoeksproduct en/of interventie
Six months of internet-based sex counselling aiming to increase the probability of natural conception of an ongoing pregnancy
Publiek
P.O. Box 22660
I. Custers
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5664355 or +31 (0)20 5669111
i.m.custers@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
I. Custers
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5664355 or +31 (0)20 5669111
i.m.custers@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Heterosexual couples with unexplained subfertility
2. ≥ 30% chance of an naturally conceived ongoing pregnancy calculated (Hunault)
3. Sufficient command of the Dutch language
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Somatic or psychological problems interfering with the couples ability to have sexual intercourse
Opzet
Deelname
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