Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorRigshospitalet, Denmark
About this trial
The aim of this randomized controlled trial is to examine whether single blastocyst transfer in the first cycle after oocyte retrieval (immediate) is non-inferior to single blastocyst transfer in a subsequent cycle (postponed) in stimulated or programmed cycle frozen embryo transfer (FET). The primary outcome is live birth rate.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eligible for FET in a programmed- or stimulated cycle immediately following a fresh embryo transfer or freeze all cycle
Oligo-anovulatory women (cycle length > 35 days)
Ovulatory women (cycle length 21-35 days)
At least one vitrified day 5 or 6 blastocyst with Gardner score of ≥ 3BB at the day of vitrification
Disqualifiers
Uterine malformation
Presence of hydrosalpinx, submucosal uterine myomas or uterine polyps
Allergies or contraindication to standard fertility medication
Male or female HIV or Hepatitis B or C
Trial design
Design model
Parallel
Treatments tested in this trial
Immediate FET in a stimulated or programmed cycle
Procedure/SurgeryPatients will undergo FET in the cycle immediately following oocyte retrieval and a failed fresh embryo transfer or freeze all.
Treatment groups
484 Participants
are divided into 2 treatment groupsGroup A: Immediate FET in a stimulated or programmed cycleExperimental treatment 1 intervention
Group B: Postponed FET in a stimulated or programmed cycleNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Live birth rate
Live birth rate in immediate FET compared to postponed FET in women undergoing FET in a stimulated or programmed cycle.
Time frame
One year follow up from positive pregnancy test.Secondary outcomes
1
Live birth rate per blastocyst transfer
Live birth rate overall in both groups
Time frame
One year follow up from positive pregnancy test.2
Ongoing pregnancy rate
Ongoing pregnancy rate where pregnancy is assessed by ultrasound in the immediate versus the postponed group
Time frame
At 7 or 8 weeks of gestation in case of pregnancy3
Miscarriage rate
Rate of pregnancy loss in the immediate versus the postponed group
Time frame
Until 22 weeks of gestation in women with positive pregnancy test4
Cancelled cycle rate and reason for cancelled cycles
Cancelled cycle rate in the immediate versus the postponed group
Time frame
Will be assessed through study participation dependent on the participants cycle up to 50 daysSponsors and contacts
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Source ClinicalTrials.gov