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van CCT (UK)

van CCT (UK)

GnRH analogues in IVF and monitoring embryo development.

- candidate number10737
- NTR NumberNTR3209
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-dec-2011
- Secondary IDsCCMO NL37697.000.11
- Public TitleGnRH analogues in IVF and monitoring embryo development.
- Scientific TitleGnRH analogues for ovarian stimulation and embryo quality: Monitoring embryo development using a time lapse incubator.
- hypothesisSelection of the best embryo for transfer is the key to achieve high implantation rates and is still largely based on morphological assessments at fixed time points. Newly emerging techniques, enabling safe time-lapse photography of embryo development, demonstrate that morphological changes occur rapidly around the time of cell division, with an initial increase in fragmentation, followed by re-uptake. Therefore, if observed at the wrong moment, good quality embryos can be erroneously classified as poor quality.
During a previous randomized trial, comparing the effect of ovarian stimulation protocols with GnRH agonist or GnRH antagonist co-treatment on embryo aneuploidy rates, we made observations indicating that GnRH antagonist embryos may be developmentally delayed in reaching the 8-cell stage on Day 3. If confirmed, optimal timing of embryo morphology assessment may be different from what is routine practice in labs optimized for GnRH agonist stimulation protocols. Morphological selection of GnRH antagonist embryos may thus occur at a suboptimal moment and lead to selection of the “wrong” embryo. Optimizing timing of embryo morphology assessment for GnRH antagonist embryos may thus result in improved embryo implantation rates.
- Healt Condition(s) or Problem(s) studiedDevelopment after in vitro fertilisation (IVF), Ovarian stimulation, IVF, EmbryoScope
- Inclusion criteria1. Female age <38 years
2. BMI <32 kg/m2
3. Partner with normal semen parameters (volume ≥ 1.5 ml, concentration: >15*10˄6, progressively motile sperm >32%, so with a VCM ≥ 7,2)
4. Standard indication for IVF
5. Undergoing first or second IVF cycle
6. Written informed consent
- Exclusion criteria1. Indication for ICSI
2. Endometriosis
3. Expected poor response
4. One previous IVF treatment not resulting in embryo transfer
5. Medical contra indication for pregnancy or IVF treatment
6. Relevant systemic disease
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2017
- planned closingdate28-feb-2018
- Target number of participants82
- InterventionsRandomization to one of two routinely applied ovarian stimulation protocols:
1. GnRH agonist long stimulation protocol with a daily dose of 150 IU recombinant FSH;
2. GnRH antagonist stimulation protocol starting with administration of 150 IU r-FSH on cycle day 2 or 5, with GnRH antagonist treatment start on stimulation day 1.
- Primary outcomeMorphokinetic parameters of embryo development.
- Secondary outcome1. Fertilization rate;
2. Embryo morphology;
3. Implantation rates;
4. Ongoing pregnancy rates.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryDuring a previous randomized trial comparing the effect of ovarian stimulation protocols with GnRH agonist or GnRH antagonist co-treatment on embryo aneuploidy rates, we made observations indicating that GnRH antagonist embryos may be developmentally delayed. This trial aims to investigate if the use of different GnRH-analogues for ovarian stimulation affects embryo developmental kinetics after IVF treatment. To chart these changes, we aim to perform time-lapse photography using the EmbryoScope™ embryo monitoring system (Unisense Fertilitech, Denmark) on embryos from IVF patients, randomized for either GnRH-agonist or antagonist co-treatment.
In both arms, oocyte pick up and insemination will be performed according to standard procedures (Day 0). After assessment of fertilization on day 1, fertilized oocytes will be transferred to specialized culture dishes and loaded in the EmbryoScopeTM. This is an incubator designed for time-lapse embryo assessment, facilitated by a specialized built-in microscope. The EmbryoScope™ provides a controlled culture environment, while acquiring images of up to 72 embryos in different focal planes every 20 minutes. Single embryo selection for transfer will be performed according to standard criteria on Day 3, and for cryopreservation on Day 4. Differences in embryo developmental kinetics will be analyzed retrospectively using the recorded images.
- Main changes (audit trail)
- RECORD21-dec-2011 - 19-feb-2017

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