Frozen Embryo Transfer (FET)CSF-EGNCT07869576
Cryopreserved Pre-embryo Transfer in a Cytokine-rich Medium Versus Hyaluronic Acid
A study testing Cytokine-rich embryo transfer medium and Hyaluronic acid-enriched embryo transfer medium in people with Frozen Embryo Transfer (FET), run by Vida Recoletas Sevilla.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Frozen Embryo Transfer (FET)
- What is being tested?
- Cytokine-rich embryo transfer medium and Hyaluronic acid-enriched embryo transfer medium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 50 years.
- Undergoing transfer of a single cryopreserved embryo (SET) from own and/or donor gametes.
Who cannot join
- Uterine malformations or conditions that, in the physician's judgment, could affect implantation.
- Transfer of more than one embryo.
- Transfer of mosaic embryos.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transferencia de Preembriones Criopreservados en un Medio Rico en Citoquinas Versus ácido hialurónico: Estudio clínico Aleatorizado
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.
Read the detailed description
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.
- Conditions
- Frozen Embryo Transfer (FET)
- Being tested
- Cytokine-rich embryo transfer medium, Hyaluronic acid-enriched embryo transfer medium
- Keywords
- frozen embryo transfer, GM-CSF, hyaluronic acid, culture media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine-rich embryo transfer mediumOther
Embryo transfer medium enriched with cytokines, used for the transfer of cryopreserved embryos.
Hyaluronic acid-enriched embryo transfer mediumOther
Embryo transfer medium enriched with hyaluronic acid, used for the transfer of cryopreserved embryos.
| Study group | Role | What they receive |
|---|---|---|
| GM-CSF-supplemented transfer medium | Experimental | Participants receive a single frozen embryo transfer using SAGE 1-Step medium with GM-CSF. Receives: Other: Cytokine-rich embryo transfer medium |
| Hyaluronic acid-enriched transfer medium | Active comparator | Participants receive a single frozen embryo transfer using EmbryoGlue medium enriched with hyaluronic acid. Receives: Other: Hyaluronic acid-enriched embryo transfer medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate per embryo transfer
Proportion of embryo transfers resulting in an intrauterine gestational sac and fetal heartbeat confirmed by ultrasound.
Measured: 6-9 weeks of gestation after embryo transfer.
Secondary outcomes (5)
Biochemical pregnancy rate per embryo transfer
Proportion of participants with a positive serum β-hCG test after embryo transfer.
Measured: 9-15 days after embryo transfer.
Ongoing pregnancy rate per embryo transfer
Proportion of participants with embryonic heartbeat detected.
Measured: 6-9 weeks of gestation after embryo transfer.
Live birth rate per embryo transfer
Proportion of participants with a live-born infant at delivery.
Measured: 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.
Measured: 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.
Measured: After ultrasound confirmation of the gestational sac; the protocol does not specify a final follow-up time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start20 Nov 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen Embryo Transfer (FET)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial with two parallel groups and 1:1 allocation according to the embryo transfer medium.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vida Recoletas Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869576
- Sponsor's protocol ID
- 2601_VAL_MA
- Acronym
- CSF-EG
- Status last verified
- Nov 2026
- First submitted
- 30 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Study results will be disseminated through publications and presentations in aggregate form.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transferencia de Preembriones Criopreservados en un Medio Rico en Citoquinas Versus ácido hialurónico: Estudio clínico Aleatorizado
- ClinicalTrials.gov ID
- NCT07869576
- Acronym / sponsor ID
- CSF-EG / 2601_VAL_MA
- Conditions
- Frozen Embryo Transfer (FET)
- Keywords
- frozen embryo transfer, GM-CSF, hyaluronic acid, culture media
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Vida Recoletas SevillaUniversity, hospital or other
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized trial with two parallel groups and 1:1 allocation according to the embryo transfer medium.
| Arm | Type | Receives |
|---|---|---|
| GM-CSF-supplemented transfer medium | Experimental | Other: Cytokine-rich embryo transfer mediumParticipants receive a single frozen embryo transfer using SAGE 1-Step medium with GM-CSF. |
| Hyaluronic acid-enriched transfer medium | Active comparator | Other: Hyaluronic acid-enriched embryo transfer mediumParticipants receive a single frozen embryo transfer using EmbryoGlue medium enriched with hyaluronic acid. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged 18 to 50 years.
- Undergoing transfer of a single cryopreserved embryo (SET) from own and/or donor gametes.
Key exclusion criteria (3 listed)
- Uterine malformations or conditions that, in the physician's judgment, could affect implantation.
- Transfer of more than one embryo.
- Transfer of mosaic embryos.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytokine-rich embryo transfer mediumEmbryo transfer medium enriched with cytokines, used for the transfer of cryopreserved embryos. | Other | GM-CSF-supplemented transfer medium |
| Hyaluronic acid-enriched embryo transfer mediumEmbryo transfer medium enriched with hyaluronic acid, used for the transfer of cryopreserved embryos. | Other | Hyaluronic acid-enriched transfer medium |
Primary outcome
Clinical pregnancy rate per embryo transfer
Time frame: 6-9 weeks of gestation after embryo transfer.
Proportion of embryo transfers resulting in an intrauterine gestational sac and fetal heartbeat confirmed by ultrasound.
5 secondary outcomes
Biochemical pregnancy rate per embryo transfer
Time frame: 9-15 days after embryo transfer.
Ongoing pregnancy rate per embryo transfer
Time frame: 6-9 weeks of gestation after embryo transfer.
Live birth rate per embryo transfer
Time frame: From embryo transfer through delivery, up to 9 months after embryo transfer.
Biochemical pregnancy loss rate per embryo transfer
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
Time frame: After ultrasound confirmation of the gestational sac; the protocol does not specify a final follow-up time point.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Study results will be disseminated through publications and presentations in aggregate form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Cytokine-rich embryo transfer medium and Hyaluronic acid-enriched embryo transfer medium in people with Frozen Embryo Transfer (FET), run by Vida Recoletas Sevilla.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolás Prados Dodd (+34 954 28 62 74, vida.investiga@gruporecoletas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate per embryo transfer (time frame: 6-9 weeks of gestation after embryo transfer.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.