To test the hypothesis that in women undergoing IVF/ICSI a freeze-all strategy results in higher ongoing pregnancy rates and is more cost-effective compared to a fresh embryo transfer.
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy rate per woman and progesterone serum level at day of
ovulation trigger.
Secondary outcome
1. multiple ongoing pregnancy rates
2. live birth rates
3. cumulative ongoing pregnancy rates
4. time to pregnancy
5. costs
6. health-related quality of life (HRQL)
7. embryologic parameters: morphology, implantation rate
8. freeze-thaw survival per centre
9. endometrial parameters: thickness, appearance
Background summary
Ovarian hyperstimulation does not only lead to the maturation of multiple
oocytes but also causes changes in the endometrium that hamper endometrium
receptivity thereby creating suboptimal implantation chances for the
transferred embryo. Disengagement of the ovarian hyperstimulation from the
embryo transfer by freezing all embryos followed by a transfer in a subsequent
unstimulated cycle, overcomes this problem. It is not known which women benefit
most from disengagement.
Study objective
To test the hypothesis that in women undergoing IVF/ICSI a freeze-all strategy
results in higher ongoing pregnancy rates and is more cost-effective compared
to a fresh embryo transfer.
Study design
multicentre marker-RCT with a cost-effectiveness analysis.
Intervention
Cryopreservation of all embryos at day 3-4 and postponed first transfer of the
embryo in an unstimulated cycle. Cryopreservation of all supernumerary embryos
and tranfser in unstimulated cycles. In both study arms a blood sample on the
day of ovulation trigger is mandatory to measure serum progesterone as a marker
for endometrium receptivity.
Study burden and risks
No incapacitated subjects nor minors are involved in this study. No risks
additional to standard treatment are associated with the study. Benefits of
participating in the study are potential higher pregnancy chances in the
freeze-all arm.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Women between 18 and 43 years of age who start their first IVF/ICSI.
Exclusion criteria
1. Women undergoing a PGD cycle.
2. Women undergoing IVF in a modified natural cycle.
3. Women undergoing IVF for oocyte donation
4. Women undergoing *rescue* IVF after overstimulation during IUI treatment.
5. Not able or willing to provide informed consent
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 | NL53643.018.15 |
| OMON | NL-OMON25760 |