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ANTARCTICA trial: Cryo-thawed embryo transfer: natural versus artificial cycle. A non inferiority trial.


- candidate number5149
- NTR NumberNTR1586
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jan-2009
- Secondary IDs23273/2008-002689-68 ABR/eudraCT
- Public TitleANTARCTICA trial: Cryo-thawed embryo transfer: natural versus artificial cycle. A non inferiority trial.
- Scientific TitleCryo-thawed embryo transfer: natural versus artificial cycle. A non inferiority trial.
- ACRONYMANTARCTICA trial
- hypothesisTo compare live birth rates among patients receiving cryo thawed embryo transfer after endometrial preparation with estrogen/progesterone substitution and patients receiving cryo thawed embryo transfer in a natural cycle.
- Healt Condition(s) or Problem(s) studiedSubfertility, In vitro fertilization (IVF)
- Inclusion criteria1. Patients between 18 en 40, planning to receive a frozen thawed embryo transfer, embryos orginated out of IVF/ICSI treatment 1,2 or 3.
2. Patients are willing to participate during 1 frozen thawed embryo transfer treatment cycle and are willing to sign informed consent.
3. Ovulatoir menstruationcycle between 26 and 35 days.
- Exclusion criteriaPatients with a contraindication for medication used in this study such as:
1. Trombo-embolic event in the patients history;
2. Severe disorder of liverfunction;
3. Estrogen sensitive tumors;
4. Breastcancer;
5. Porfyria;
6. Patients with a known allergy for one of the used medicines;
7. Patients with anovulatory menstruation cycles;
8. Patients with uterine abnormalities;
9. Patients with cryo embryos derrived from oocyte donation.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2009
- planned closingdate1-mrt-2012
- Target number of participants1150
- InterventionsCryo thawed embryo transfer in natural cycle versus artificial cycle.
- Primary outcomeLive birth rate.
- Secondary outcome1. Clinical pregnancy, ongoing pregnancy, cancellation rates (per started cryo cycle).
2. Endometrial growth.
3. Cost efficiancy and analyses of the burden of treatment.
4. SAE.
- TimepointsNo interim analysis will be performed. Total duration of the study will be 3 years (+ 9 months follow up of pregnant subjects).
- Trial web sitewww.antracticatrial.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESdrs. E.R. Groenewoud
- CONTACT for SCIENTIFIC QUERIESdrs. E.R. Groenewoud
- Sponsor/Initiator Isala Clinics Zwolle
- Funding
(Source(s) of Monetary or Material Support)
Stichting Fertiliteitsafdeling
- Publications
- Brief summaryCryopreservation of embryos derived from IVF or IVF-ICSI treatment is a save and cost efficient supplement to regular IVF treatment. Before transferring the embryoís into the uterus itís necessary to synchronise development of embryo and endometrium. This synchronisation is essential for the success of the treatment. Because of this need cryo embryo transfer needs planning en preparation. The are several methods of endometrial preparation preceding frozen thawed embryo transfer. Most common are natural cycle and artificial cycle preparation. Both are accepted methods of endometrium preparation and itís common opinion that live birth rates are comparable. Despite this claim so far no randomised study has been undertaken to confirm this statement.
- Main changes (audit trail)
- RECORD13-jan-2009 - 28-jan-2009


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