search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Freeze-all


- candidate number22411
- NTR NumberNTR5235
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jul-2015
- Secondary IDsNL53643.018.15 
- Public TitleFreeze-all
- Scientific TitleThe freeze-all strategy in IVF: who benefits?
- ACRONYMFreeze-all
- hypothesisIn 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.
- Healt Condition(s) or Problem(s) studiedIVF, Progesterone, Endometrium
- Inclusion criteriaWomen between 18 and 43 years of age who start their first IVF/ICSI.
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate26-dec-2018
- Target number of participants900
- InterventionsCryopreservation 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.
- Primary outcomeOngoing pregnancy rate per woman and progesterone serum level at day of ovulation trigger.
- Secondary outcome1. 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
- Timepoints48 months
- Trial web sitehttp://www.studies-obsgyn.nl/freeze-all/page.asp?page_id=1645
- statusstopped
- CONTACT FOR PUBLIC QUERIESdr. F. Mol
- CONTACT for SCIENTIFIC QUERIESdr. F. Mol
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryBackground of the study: 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. Objective of the study: 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.
Study population: Subfertile women between 18 and 43 years undergoing IVF/ICSI.
Intervention (if applicable):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.
Primary study parameters/outcome of the study: Ongoing pregnancy rate per woman and progesterone serum level at day of ovulation trigger.
Secundary study parameters/outcome of the study (if applicable):
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
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable): 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.
- Main changes (audit trail)4-apr-2016: Trial not started, investigators are no longer in equipoise-EB
- RECORD3-jul-2015 - 4-apr-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl