None listed
Conditions
Brief summary
This study will test whether freezing all good or top quality day 5-6 embryos after IVF and subsequently thawing and transferring the best day 5-6 embryo into a natural or artificially prepared cycle leads to an increase in the probability of delivering a live baby from 35% to 50% as compared to the standard strategy of treatment which includes transferring the best quality day 5-6 embryo fresh and cryopreserving the remaining good or top quality embryos.
Interventions
Triggering of final oocyte maturation will be performed in the freeze-all arm with a bolus subcutaneous injection of 2 mg of leuprolide acetate when at least three follicles equal to or greater than 17mm in mean diameter are present at ultrasound. Oocyte retrieval will be performed at 34-36h after leuprolide administration.
Embryos will be cultured for 5 days using the standard protocol of each clinic. All day 5 embryos of top and good quality (at least at early blastocyst stage and of ICM/Troph
Triggering of final oocyte maturation will be performed in the freeze-all arm with a bolus subcutaneous injection of 2 mg of leuprolide acetate when at least three follicles equal to or greater than 17mm in mean diameter are present at ultrasound. Oocyte retrieval will be performed at 34-36h after leuprolide administration. Embryos will be cultured for 5 days using the standard protocol of each clinic. All day 5 embryos of top and good quality (at least at early blastocyst stage and of ICM/Trophectoderm: AA, AB, BA, BB) will be cryopreserved using the method of vitrification. If only one embryo is available, this embryo will be vitrified regardless of quality as long as full embryo compaction has occurred. Delayed embryos will be allowed to be vitrified on day 6 as long as they fulfill the quality criteria (at least at early blastocyst stage and of ICM/Trophectoderm: AA, AB, BA, BB). Prior to freezing of embryos the developmental stage and quality of the blastocysts will be recorded (based on the judgement of the embryologist). Each blastocyst will be frozen in it’s own straw. Based on the pre-vitrification morphological quality, the best blastocyst will be thawed for the next embryo transfer. If the blastocyst does not survive, the next best blastocyst (based again on the pre-vitrification morphological criteria) will be thawed. The maximum period of embryo cryopreservation is theoretically indefinite, however it rarely exceeds five years. For the primary outcome of this study, the embryo cryopreservation period is estimated between 20 days-3 months. Hence, thawing and embryo transfer is expected to occur within this timeframe. Vitrification will be performed according to established local laboratory protocols with the use of TGA approved Vitrification solutions (Vitrolife or Sage). Vitrification will be performed at either 37 degrees Celsius or room temperature.
Sponsors
IVFAustralia Pty L.t.d.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
1) Indication for COS and IVF or ICSI with autologous gametes 2) Age: 18-39 years 3) BMI: 18-32 kg/m2 4) Presence of both ovaries 5) Normal menstruating cycles: 21-35 days 6) Cycle where prevention of premature LH rise is achieved using a GnRH antagonist 7) 8-19 follicles equal to or greater than 10mm in mean diameter on the day of triggering
Exclusion criteria
1) Endometriosis Stage>II 2) Indication for PGD/PGS 3) History of OHSS 4) Previous participation in the RCT 5) >3 previous unsuccessful stimulated cycles 6) History of hypothalamic dysfunction or history of inadequate pituitary response to GnRH agonist triggering
Outcome results
None listed