Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer: a Multicenter Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 484
- Locations
- 1
- Primary Endpoint
- Live birth rate
Study Overview
Brief Summary
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.
Detailed Description
This is a multicenter randomized controlled trial with the aim of investigating if FET in the first cycle after oocyte retrieval (immediate) is non-inferior to the standard treatment where FET is postponed to a subsequent cycle.
Patient inclusion is set to begin in February 2024 and continue til August 2028. A total of 484 patients will be included according to the inclusion and exclusion criteria.
Patients will be randomized 1:1 to either immediate or postponed FET. Randomization is stratified for stimulated FET with letrozole, stimulated FET with gonadotropins and programmed FET (estradiol and progesterone treatment).
The study groups will be:
- FET immediate: Programmed cycle (PC) or Stimulated cycle (SC) FET in the first cycle after oocyte retrieval and fresh embryo transfer or freeze-all.
- FET postponed: PC or SC FET after at least one cycle following oocyte retrieval and fresh embryo transfer or freeze-all.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •Preimplantation genetic testing (PGT) in the fresh cycle
- •Testicular sperm aspiration (TESA)
- •Severe OHSS with hospital admission and ascites drainage during the fresh cycle
- •Oocyte donation
Arms & Interventions
Immediate FET in a stimulated or programmed cycle
Stimulated or programmed cycle FET is performed in the first cycle following failed fresh embryo transfer or freeze all.
Intervention: Immediate FET in a stimulated or programmed cycle (Procedure)
Postponed FET in a stimulated or programmed cycle
Stimulated or programmed cycle FET is performed at least one full menstrual, or one hormonal replacement treatment (HRT) cycle in case of oligo-anovulation, after the fresh embryo transfer or freeze-all cycle
Outcomes
Primary Outcomes
Live birth rate
Time Frame: One year follow up from positive pregnancy test.
Live birth rate in immediate FET compared to postponed FET in women undergoing FET in a stimulated or programmed cycle.
Secondary Outcomes
- Endocrinology of the luteal phase(Through each participants cycle, will be dependent on participants cycle up to 50 days)
- Miscarriage rate(Until 22 weeks of gestation in women with positive pregnancy test)
- Neonatal outcomes (weight in kilograms)(One year follow up from positive pregnancy test)
- Ongoing pregnancy rate(At 7 or 8 weeks of gestation in case of pregnancy)
- Live birth rate per blastocyst transfer(One year follow up from positive pregnancy test.)
- Cancelled cycle rate and reason for cancelled cycles(Will be assessed through study participation dependent on the participants cycle up to 50 days)
- Time-to-pregnancy(From day of ovarian stimulation until clinical pregnancy dependent on participants cycle length up to 70 days)
- Pregnancy related complications(One year follow up from positive pregnancy test)
- Neonatal outcomes (length in cm)(One year follow up from positive pregnancy test)
- Number of ovarian follicular structures >10 mm(Twice through the cycle, dependent on participants cycle length up to 50 days)
- Time-to-live-birth(From day of ovarian stimulation through study completion up to 1 year)
- Neonatal outcomes (apgar score at 1, 5 and 10 minutes postpartum)(One year follow up from positive pregnancy test)
- Quality of life based on the Copenhagen Multicenter Psychosocial Infertility (COMPI) stress scale questionnaires(Questionnaires will be handed out at baseline and after blastocyst transfer timeframe will depend on the participants cycle up to 50 days)
Investigators
Anja Bisgaard Pinborg
Prof. DMSc
Rigshospitalet, Denmark