No registrations found.
ID
Source
Health condition
IVF, in vitro fertilization, unexplained infertility, advanced age, 38 years old, ovarian aging, in vitro fertilisatie, onverklaarde subfertiliteit, ovariele veroudering
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is ongoing pregnancy resulting in live birth, conceived within a period of 8 months after randomisation
Secondary outcome
Secondary outcomes are clinical pregnancy, multiple pregnancy, miscarriage, pregnancy complications, premature birth, couples¡¯ preferences, quality of life and costs. In a cost-effectiveness analysis, we will calculate incremental costs per ongoing pregnancy conceived within a time horizon of 8 months after randomisation comparing IVF to expectant management.
Study objective
Our hypothesis is that 8 months IVF results in 10% higher pregnancy rates leading to a live birth compared to 8 months expectant management.
Study design
a time horizon of 8 months after randomisation
Intervention
IVF treatment versus expectant management
M.H. Mochtar
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
020-5669111
m.h.mochtar@amc.uva.nl
M.H. Mochtar
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
020-5669111
m.h.mochtar@amc.uva.nl
Inclusion criteria
- Age at least 38 and younger than 42 (women must be 38, 39, 40, or 41 at inclusion).
- Had unprotected regular intercourse during at least 12 months without conception.
- Normal regular ovulatory cycle between 26 and 34 days as confirmed by either history,
basal temperature curve, ultrasound monitoring or serum progesterone
- Tubal patency of at least one tube as established with either hysterosalpingography,
contrastsonography, or diagnostic laparoscopy, or a confirmed earlier intra-uterine pregnancy (miscarriage or ongoing) not through IVF.
- Partners with normal or mildly impaired semen quality (TMSC ¡Ý 3 million).
Exclusion criteria
- Age <38 or >42 at the time of inclusion
- Irregular cycle, defined as < 25 days or >34 days.
- Double sided tubal occlusion
- Poor semen quality (TMSC <3 million)
- Couples undergoing IVF combined with Pre-implantation Genetic Diagnosis
- Couples undergoing ICSI combined with TESE (testiculair spermextraction)
- Couples undergoing IVF or ICSI with donor sperm
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5384 |
| NTR-old | NTR5484 |
| CCMO | NL42977.018.15 |
| OMON | NL-OMON50639 |