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No participants met the inclusion criteria in an exted period of time.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fresh ET | No Intervention | The best available embryo is at expansion grade <4 by Gardner classification 5 days after oocyte retrieval. Patient's embryos are cultured to day 6 and transferred regardless of expansion grade. Arrested blastocysts are discarded. | |
| Frozen Embryo Transfer | Experimental | The best available embryo is at expansion grade <4 by Gardner classification 5 days after oocyte retrieval. Patient's embryos are cultured to day 6 and vitrified regardless of expansion grade. Arrested blastocysts are discarded. The single best available embryo is transferred under a cryo-synthetic cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frozen Embryo Transfer | Procedure | Patient's embryos are cultured to day 6, vitrified and transferred in a cryo-synthetic cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy Rate | Proportion of patients with the presence of a gestational sac seen by transvaginal ultrasonography 20 days after the embryo transfer | 20 days after date of embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Pregnancy Rate | Proportion of patients with the detection of β-hCG level ≥5 mIU/mL 9 days after the embryo transfer | 9 days after date of embryo transfer |
| Live Birth Rate | Proportion of patients which deliver a live infant after 24 weeks of gestation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Rodriguez-Purata, MD | Fundacion Dexeus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitari Dexeus | Barcelona | 08022 | Spain |
all collected IPD
January 2020
All
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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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
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| 24 weeks after the embryo transfer |
| Miscarriage Rate | Proportion of patients with a pregnancy loss following a positive pregnancy test and/or detectable gestacional sac | 14 weeks after the embryo transfer |
| Cryopreservation-thaw rate | Proportion of vitrified blastocysts which survive the re-warming | 1 day after the thawing procedure |