Infertility
Conditions
Keywords
In vitro Fertilization, Slow Developing Blastocyst, Fresh Embryo Transfer, Frozen Embryo Transfer, Live Birth Rate
Brief summary
This study evaluates which transfer strategy will result in a higher probability of pregnancy in patients whose single best day 5 embryo resulting from an IVF cycle is classified as expansion grade \<4 by Gardner and Schoolcraft classification. All cycles will be cultured to day 6 and half the patients will undergo a fresh embryo transfer and the other half a frozen embryo transfer.
Detailed description
A lack of established markers for predicting blastocyst development increases the risk of having no embryos or embryos not-fully expanded available for transfer. Slower but non-arrested embryos are frequently found to have progressed to blastocyst stage by the time of a day 6 transfer. In the absence of a receptive endometrium, embryo selection for fresh transfer may be futile, and cryopreservation could be a better option. The objective is to determine which transfer strategy will result in a higher probability of pregnancy in patients whose single best day 5 embryo resulting from an IVF cycle is classified as expansion grade \<4 by Gardner and Schoolcraft classification. The investigators hypothesize that in bad prognosis patients with slow-developing blastocysts, vitrified-warmed embryo transfer will result in higher implantation, clinical and ongoing pregnancy and live birth rates than fresh embryo transfer.
Interventions
PROCEDUREFrozen Embryo Transfer
Patient's embryos are cultured to day 6, vitrified and transferred in a cryo-synthetic cycle
Sponsors
Fundacion Dexeus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will be randomized by an intention to treat approach. Randomization at the blastocyst stage is chosen to avoid cycle cancellation if randomized earlier. All components of the IVF/ICSI cycle including stimulation medications, monitoring protocols, etc. will be at the discretion of the participant's primary physician; while this information will be documented it will not constitute criteria for enrolment. The group allocation will take place the day of the embryo transfer. The clinician will randomize all included patients into one of the two study groups using an open computer-generated list. An interim analysis is planned and sample size will be plan accordingly, under the Pocok method, including 2 stages, with p-value as boundary scale, calculated to have 80% power to detect a 20% difference with a reference proportion of 25% clinical pregnancy rate and a one-sided (upper) alpha of 0.025
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* All IVF cycles undergoing autologous fresh blastocyst embryo transfer * All IVF cycles in which the best available embryo for transfer is at expansion grade \<4 * All ages
Exclusion criteria
* Ovum Donation cycles * Preimplantation genetic testing cycles
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy Rate | 20 days after date of embryo transfer | Proportion of patients with the presence of a gestational sac seen by transvaginal ultrasonography 20 days after the embryo transfer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Pregnancy Rate | 9 days after date of embryo transfer | Proportion of patients with the detection of β-hCG level ≥5 mIU/mL 9 days after the embryo transfer |
| Live Birth Rate | 24 weeks after the embryo transfer | Proportion of patients which deliver a live infant after 24 weeks of gestation |
| Miscarriage Rate | 14 weeks after the embryo transfer | Proportion of patients with a pregnancy loss following a positive pregnancy test and/or detectable gestacional sac |
| Cryopreservation-thaw rate | 1 day after the thawing procedure | Proportion of vitrified blastocysts which survive the re-warming |
Countries
Spain
Outcome results
None listed