Health TrialsbyHealthPanel

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

ConditionFrozen Embryo Transfer (FET)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorVida Recoletas Sevilla

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 18 to 50 years.

Undergoing transfer of a single cryopreserved embryo (SET) from own and/or donor gametes.

Disqualifiers

Uterine malformations or conditions that, in the physician's judgment, could affect implantation.

Transfer of more than one embryo.

Transfer of mosaic embryos.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cytokine-rich embryo transfer medium

    Other intervention

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

  • Hyaluronic acid-enriched embryo transfer medium

    Other intervention

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

Treatment groups

610 Participants
are divided into 2 treatment groups
Group A: GM-CSF-supplemented transfer mediumExperimental treatment 1 intervention
Group B: Hyaluronic acid-enriched transfer mediumActive comparator 1 intervention

Trial outcomes

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.

Time frame
6-9 weeks of gestation after embryo transfer.

Secondary outcomes

1

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.
2

Ongoing pregnancy rate per embryo transfer

Proportion of participants with embryonic heartbeat detected.

Time frame
6-9 weeks of gestation after embryo transfer.
3

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.
4

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vida Recoletas Sevilla

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: