Cryopreserved Pre-embryo Transfer in a Cytokine-rich Medium Versus Hyaluronic Acid

NCT07869576 | Not Yet Recruiting

• 1 other identifier: 2601_VAL_MA
• Study Type: interventional
• Target: 610
• Locations: 0 countries
• Sites: N/A

Brief 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. Participants will be randomly assigned to one of the two groups.

Conditions

Frozen Embryo Transfer (FET)

Keywords

frozen embryo transfer; GM-CSF; hyaluronic acid; culture media

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate per embryo transfer

  Proportion of embryo transfers resulting in an intrauterine gestational sac and fetal heartbeat confirmed by ultrasound.

  6-9 weeks of gestation after embryo transfer.

Secondary Outcomes (5)

• Biochemical pregnancy rate per embryo transfer

  9-15 days after embryo transfer.

• Ongoing pregnancy rate per embryo transfer

  6-9 weeks of gestation after embryo transfer.

• Live birth rate per embryo transfer

  From embryo transfer through delivery, up to 9 months after embryo transfer.

• Biochemical pregnancy loss rate per embryo transfer

  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

  After ultrasound confirmation of the gestational sac; the protocol does not specify a final follow-up time point.

Study Arms (2)

GM-CSF-supplemented transfer medium

EXPERIMENTAL

Participants receive a single frozen embryo transfer using SAGE 1-Step medium with GM-CSF.

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.

Other: Hyaluronic acid-enriched embryo transfer medium

Interventions

Cytokine-rich embryo transfer medium OTHER

Embryo transfer medium enriched with cytokines, used for the transfer of cryopreserved embryos.

GM-CSF-supplemented transfer medium

Hyaluronic acid-enriched embryo transfer medium OTHER

Embryo transfer medium enriched with hyaluronic acid, used for the transfer of cryopreserved embryos.

Hyaluronic acid-enriched transfer medium

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 to 50 years.
• Undergoing transfer of a single cryopreserved embryo (SET) from own and/or donor gametes.

You may not qualify if:

• Uterine malformations or conditions that, in the physician's judgment, could affect implantation.
• Transfer of more than one embryo.
• Transfer of mosaic embryos.

Sponsors & Collaborators

• Vida Recoletas Sevilla: lead

Central Study Contacts

Nicolás Prados Dodd

CONTACT

+34 954 28 62 74; vida.investiga@gruporecoletas.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized trial with two parallel groups and 1:1 allocation according to the embryo transfer medium.

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share