In view of this uncertainty in which current practice in IVF is applied in *older* women, we propose a nationwide randomized trial comparing IVF with natural conception.
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy rate leading to live birth
Secondary outcome
- IVF outcome parameters, such as the total number of follicles, oocytes, MFII
oocytes, germinal vesicles.
- Poor ovarian response defined as the growth of less than 3 follicles of > 14
mm. under maximal ovarian stimulation of 225 EH FSH.
- Total number of embryo*s and embryo quality.
- Clinical pregnancy; defined as the presence of a gestational sac seen by
transvaginal sonography 5-7 weeks after embryo tranfer
- Ongoing pregnancy; defined as the presence of positive heart beat as seen by
transvaginal sonography 10 weeks after embryo transfer.
- Multiple pregnancy; defined as two or more gestational sacs seen by
transvaginal sonography 5-7 weeks after embryo transfer
- Ongoing multiple pregnancy; defined as two or more positive heart beats seen
by transvaginal sonography 10 weeks after embryo transfer
- Miscarriage; defined as the loss of a pregnancy prior to 16 weeks gestation
- Ectopic pregnancy, defined as the ectopic nidation of a pregnancy, confirmed
with sonography or laparoscopy
- Couples* preference, measured by means of a DCE (discrete choice experiment)
(100 patients)
- Generic quality of life measured by questionnaires (SF36 and fertiQoL) (100
patients), women in the expectant arm will be ask to keep a diary.
- Financial Costs
Background summary
Currently, 8,750 IVF and 8,250 IVF/ICSI cycles are performed in the Netherlands
every year for an average cost of approximately ยค3,000 per cycle. This number
of cycles is strongly growing, and has almost doubled in the last decade. In
approximately 1 in 4 couples with unfulfilled child wish no causal reason for
their fertility problem can be found, but for the fact the woman is
reproductively old, i.e. above the age of 38. Nevertheless, such couples are
usually treated with IVF. This is worrisome, as in these women IVF, which was
originally developed for women with obstructed tubes, has never been compared
with natural conception over a longer period of time. It may well be that IVF
does not at all counteract the natural decline in female fertility. Cohort
studies indicate that increased female age is the single most negative
prognostic factor in IVF. Moreover, there is emerging evidence that the IVF
children have lower birth weight, higher blood pressure and impaired glucose
metabolism.
Study objective
In view of this uncertainty in which current practice in IVF is applied in
*older* women, we propose a nationwide randomized trial comparing IVF with
natural conception.
Study design
Multicenter randomised clinical trial with an economic analysis alongside it.
Intervention
A maximum of three cycles of IVF treatment versus natural conception within a
time horizon of 8 months.
Study burden and risks
As we compare strategies that are already applied in current practice, no
additional risks or burdens are expected from the study.
Meibergdreef 9
Amsterdam 1104 AZ
NL
Meibergdreef 9
Amsterdam 1104 AZ
NL
Listed location countries
Age
Inclusion criteria
-- Age at least 38 and younger than 42.
- 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, or a negative history of tubal damage in combination with a negative CAT
result.
- partners with normal or mildly impaired semen quality (TMSC * 3 million).
Exclusion criteria
- Age <38 or > 41 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
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL42977.018.15 |
| OMON | NL-OMON26052 |