We hypothesize that 6 months of expectant management does not result in decreased ongoing pregnancy rates as 6 months of treatment with IUI-OH.
ID
Bron
Verkorte titel
Aandoening
Unexplained subfertility, onverklaarde subfertiliteit, intrauterine insemination, intra uteriene inseminatie, IUI, expectant management, expectatief
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is ongoing pregnancy leading to a live birth occurring within 6 months after randomization. Live birth is defined as the birth of a live baby at 24 or more weeks of gestation.
Achtergrond van het onderzoek
BACKGROUND: Of the 20,000 couples who yearly seek fertility treatment, more than 50% are diagnosed with unexplained or mild male factor subfertility. In The Netherlands, the first line treatment for these women is intrauterine insemination with ovarian hyperstimulation (IUI-OH) if the probability of a natural conception within the following year is lower than 30% according
to the validated model of Hunault. An estimated 28,500 cycles are conducted every year in the Netherlands, costing approximately 20 million euros, without any evidence that IUI-OH increases live birth rate compared to expectant management. Besides the costs, IUI-OH bears a risk of multiple pregnancies. Women with a multiple pregnancy have an increased risk of premature birth, with associated neonatal mortality and morbidity.
THE PRIMARY OBJECTIVE: To evaluate whether expectant management for 6 months does not lead to a decrease in ongoing pregnancy rate leading to a live birth compared to 6 months IUI-OH.
HYPOTHESIS: We hypothesize that 6 months of expectant management does not result in decreased ongoing pregnancy rates compared to 6 months of treatment with IUI-OH.
STUDY DESIGN: randomized multicentre, non-inferiority trial with cost-effectiveness analysis.
STUDY POPULATION Couples diagnosed with unexplained or mild male subfertility according to the Dutch guideline and an unfavourable prognosis for natural onception.
INTERVENTION: 6 months expectant management.
STANDARD INTERVENTION TO BE COMPARED: 6 months IUI-OH .
OUTCOME MEASURES: Ongoing pregnancies leading to a live birth conceived within 6 months after randomisation
SAMPLE SIZE: We expect a 30% live birth rate after 6 months IUI-COH. To evaluate whether 6 months expectant management does not result in a decrease of an ongoing pregnancy rate of 7%, we need 982 patients. (power 80%, alpha error 0.05). Anticipating 10% lost to follow up, we need to randomise 1,091 women.
Doel van het onderzoek
We hypothesize that 6 months of expectant management does not result in decreased ongoing pregnancy rates as 6 months of treatment with IUI-OH.
Onderzoeksopzet
6 months
Onderzoeksproduct en/of interventie
Expectant management (experimental arm) vs intra uterine insemination with ovarian hyperstimulation (control arm)
Publiek
F. Mol
Amsterdam
The Netherlands
020 5663557
f.mol@amsterdamumc.nl
Wetenschappelijk
F. Mol
Amsterdam
The Netherlands
020 5663557
f.mol@amsterdamumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
12 months unprotected intercourse without conception, female age between 18 and 42 years, a regular ovulatory cycle and at least one patent fallopian tube. The male partner has no or a mild impairment of semen quality with a total motile sperm count (TMSC or VCM) above 3 million. Obtained written informed consent. A 12-month prognosis for natural conception (calculated according to the model of Hunault) of 30% or less, or a 12-month prognosis of more than 30% and returning after 6 months of expectant management without conception.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
IUI-OH with sperm donation, couples with a medical contra indication for pregnancy, couples with previous ART in the current treatment episode
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5455 |
| NTR-old | NTR5599 |
| Ander register | AMC : 80-83700-98-16505 |