Clinical trial NCT03360097: Clinical Outcomes of Slow Developing Blastocysts
Official title: Pregnancy Outcomes in Patients With Slow Developing Blastocysts: What is the Best Transfer Strategy? A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: In vitro Fertilization
Slow Developing Blastocyst
Fresh Embryo Transfer
Frozen Embryo Transfer
Live Birth Rate
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 20 days after date of embryo transfer
Secondary outcomes:
measure: Biochemical Pregnancy Rate
timeFrame: 9 days after date of embryo transfer
measure: Live Birth Rate
timeFrame: 24 weeks after the embryo transfer
measure: Miscarriage Rate
timeFrame: 14 weeks after the embryo transfer
measure: Cryopreservation-thaw rate
timeFrame: 1 day after the thawing procedure
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut Universitari Dexeus
Study officials:
affiliation: Fundacion Dexeus
name: Jorge Rodriguez-Purata, MD
role: PRINCIPAL_INVESTIGATOR
References: