In one third of subfertile couples male subfertility is diagnosed. Current treatments for male subfertility, IUI, IVF and ICSI, have,despite their widespread use, not been compared on their cost-effectiveness. The primary aim of this project is to…
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy leading to live birth
Secondary outcome
Time to pregnancy, miscarriage, multiple pregnancy, live birth, pregnancy
complications, perinatal outcome, (in-)direct costs, quality of life and
patient preferences
Background summary
We hypothesize that less invasive therapies for male subfertility are
cost-effective compare to more invasive therapies.
Study objective
In one third of subfertile couples male subfertility is diagnosed. Current
treatments for male subfertility, IUI, IVF and ICSI, have,
despite their widespread use, not been compared on their cost-effectiveness.
The primary aim of this project is to assess the
cost-effectiveness of therapies for male subfertility.
Study design
Two parallel RCTs:
1. IUI versus expectant management in mild male subfertility.
2. ICSI versus IVF in severe male subfertility.
Intervention
RCT 1: 3 cycles of IUI, followed by 3 cycles of IUI-COH. Control: expectant
management. Treatment time horizon 6 months.
RCT 2: 3 cycles of ICSI, including transfer of cryoembryos. Control: 3 cycles
of IVF, including transfer of cryopreserved
embryos. Treatment time horizon 12 months.
Study burden and risks
Nature and extent of the burden and risks for the patients will be the same as
they are with the treatments for male subfertility we use nowadays. Only to
fill in some questionnaires the patients need some extra time compare to
patients who will not participate in our study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
RCT 1:
- Male subfertility: Pre-wash TMSC < 10.10^6 & > 3.10^6
- Age female partner 18-42 years
- Failure to conceive for at least 12
- Couple who start treatment for a first, or first after a successful pregnancy, cycle
RCT 2
- Age female partner between: 18-42 years
- Male subfertility: Pre-wash TMSC < 3.10^6
- Treatment naive or failure to conceive during IUI-treatment or first IVF/ICSI cycle after birth of a child
Exclusion criteria
RCT 1:
- Female partner with polycystic ovary syndrome or any other anovulation, severe endometriosis, double-sided tubal pathology, endocrinopathological disease (Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, imminent ovarian failure, premature ovarian failure, hypothalamic amenorrhea and diabetes mellitus (type I)
- Major uterine or ovarian abnormalities detected by TVS which is classified as contraindication for pregnancy or medically assisted reproduction
RCT 2:
- Severe male subfertility: Post-wash TMSC < 300.10^3
- Major uterine or ovarian abnormalities detected by TVS which is classified as contraindication for pregnancy or medically assisted reproduction
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 | NL42194.018.13 |