An interventional study of Cytokine-rich embryo transfer medium and Hyaluronic acid-enriched embryo transfer medium in Frozen Embryo Transfer (FET), sponsored by Vida Recoletas Sevilla. Not yet recruiting. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Vida Recoletas Sevilla · Not applicable, Interventional, and Treatment
This multicenter, randomized, double-blind study compares a GM-CSF-enriched embryo transfer medium with a hyaluronic acid-enriched medium in women undergoing single frozen embryo transfer. It will assess whether the GM-CSF medium is non-inferior for clinical pregnancy rates. Participants will be randomly assigned to one of the two groups.
Hyaluronic acid is commonly used in embryo transfer media to support embryo-endometrial adhesion. GM-CSF is a cytokine that may help regulate cellular stress and apoptosis after embryo warming. This study will compare a GM-CSF-supplemented transfer medium with a hyaluronic acid-supplemented medium in frozen embryo transfer cycles. Its primary aim is to determine whether the GM-CSF medium is non-inferior to the hyaluronic acid medium for clinical pregnancy. The results may help inform the choice of transfer medium in assisted reproduction.
Vida Recoletas Sevilla is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Participants receive a single frozen embryo transfer using SAGE 1-Step medium with GM-CSF.
Other: Cytokine-rich embryo transfer medium
Participants receive a single frozen embryo transfer using EmbryoGlue medium enriched with hyaluronic acid.
Other: Hyaluronic acid-enriched embryo transfer medium
Embryo transfer medium enriched with cytokines, used for the transfer of cryopreserved embryos.
Embryo transfer medium enriched with hyaluronic acid, used for the transfer of cryopreserved embryos.
Clinical pregnancy rate per embryo transfer
Proportion of embryo transfers resulting in an intrauterine gestational sac and fetal heartbeat confirmed by ultrasound.
Time frame: 6-9 weeks of gestation after embryo transfer.
Biochemical pregnancy rate per embryo transfer
Proportion of participants with a positive serum β-hCG test after embryo transfer.
Time frame: 9-15 days after embryo transfer.
Ongoing pregnancy rate per embryo transfer
Proportion of participants with embryonic heartbeat detected.
Time frame: 6-9 weeks of gestation after embryo transfer.
Live birth rate per embryo transfer
Proportion of participants with a live-born infant at delivery.
Time frame: From embryo transfer through delivery, up to 9 months after embryo transfer.
Biochemical pregnancy loss rate per embryo transfer
Pregnancy loss after a positive or indeterminate β-hCG result, without ultrasound confirmation of a gestational sac.
Time frame: From serum β-hCG testing at 9-15 days after embryo transfer through ultrasound assessment at 6-9 weeks of gestation.
Clinical pregnancy loss rate per embryo transfer
Pregnancy loss after an intrauterine gestational sac has been confirmed.
Time frame: After ultrasound confirmation of the gestational sac; the protocol does not specify a final follow-up time point.
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared with other researchers. Study results will be disseminated through publications and presentations in aggregate form.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Vida Recoletas Sevilla