Our hypothesis is that 8 months IVF results in 10% higher pregnancy rates leading to a live birth compared to 8 months expectant management.
ID
Bron
Aandoening
IVF, in vitro fertilization, unexplained infertility, advanced age, 38 years old, ovarian aging, in vitro fertilisatie, onverklaarde subfertiliteit, ovariele veroudering
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is ongoing pregnancy resulting in live birth, conceived within a period of 8 months after randomisation
Doel van het onderzoek
Our hypothesis is that 8 months IVF results in 10% higher pregnancy rates leading to a live birth compared to 8 months expectant management.
Onderzoeksopzet
a time horizon of 8 months after randomisation
Onderzoeksproduct en/of interventie
IVF treatment versus expectant management
Algemeen / deelnemers
M.H. Mochtar
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
020-5669111
m.h.mochtar@amc.uva.nl
Wetenschappers
M.H. Mochtar
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
020-5669111
m.h.mochtar@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5384 |
| NTR-old | NTR5484 |
| CCMO | NL42977.018.15 |
| OMON | NL-OMON50639 |