Infertility Clinical Trial
Official title:
Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer: a Multicenter Randomized Controlled 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.
Status | Recruiting |
Enrollment | 484 |
Est. completion date | August 1, 2028 |
Est. primary completion date | August 1, 2028 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Fertility Departmen, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Live birth rate | Live birth rate in immediate FET compared to postponed FET in women undergoing FET in a stimulated or programmed cycle. | One year follow up from positive pregnancy test. | |
Secondary | Live birth rate per blastocyst transfer | Live birth rate overall in both groups | One year follow up from positive pregnancy test. | |
Secondary | Ongoing pregnancy rate | Ongoing pregnancy rate where pregnancy is assessed by ultrasound in the immediate versus the postponed group | At 7 or 8 weeks of gestation in case of pregnancy | |
Secondary | Miscarriage rate | Rate of pregnancy loss in the immediate versus the postponed group | Until 22 weeks of gestation in women with positive pregnancy test | |
Secondary | Cancelled cycle rate and reason for cancelled cycles | Cancelled cycle rate in the immediate versus the postponed group | Will be assessed through study participation dependent on the participants cycle up to 50 days | |
Secondary | Endocrinology of the luteal phase | Hormone levels at predefined time-points in the immediate versus the postponed group | Through each participants cycle, will be dependent on participants cycle up to 50 days | |
Secondary | Number of ovarian follicular structures >10 mm | Number of ovarian follicular structures >10 mm in the immediate versus postponed arm | Twice through the cycle, dependent on participants cycle length up to 50 days | |
Secondary | Time-to-pregnancy | Time-to-pregnancy in the immediate versus postponed arm | From day of ovarian stimulation until clinical pregnancy dependent on participants cycle length up to 70 days | |
Secondary | Time-to-live-birth | Time-to-live-birth in the immediate versus postponed arm | From day of ovarian stimulation through study completion up to 1 year | |
Secondary | Pregnancy related complications | Pregnancy related complications in patients receiving immediate versus postponed FET | One year follow up from positive pregnancy test | |
Secondary | Neonatal outcomes (weight in kilograms) | Neonatal outcome in children of patients in patients receiving immediate versus postponed FET | One year follow up from positive pregnancy test | |
Secondary | Neonatal outcomes (length in cm) | Neonatal outcome in children of patients in patients receiving immediate versus postponed FET | One year follow up from positive pregnancy test | |
Secondary | Neonatal outcomes (apgar score at 1, 5 and 10 minutes postpartum) | Neonatal outcome in children of patients in patients receiving immediate versus postponed FET. The apgar score is reported on a scale of 0-10, 10 being the highest score. | One year follow up from positive pregnancy test | |
Secondary | Quality of life based on the Copenhagen Multicenter Psychosocial Infertility (COMPI) stress scale questionnaires | Quality of life in the immediate versus postponed arm. Reported on scales of "excellent, very good, good, fair or poor" or on a scale of "all the time, most of the time, sometimes, a little of the time, none of the time". | Questionnaires will be handed out at baseline and after blastocyst transfer timeframe will depend on the participants cycle up to 50 days |
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