InfertilityNCT06304792
Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer
A study testing Immediate FET in a stimulated or programmed cycle in people with Infertility and IVF, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, IVF
- What is being tested?
- Immediate FET in a stimulated or programmed cycle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2024to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Fertility Departmen, Rigshospitalet
Copenhagen, 2100
Anja B. Pinborg, Prof., DMSC, 0045 35 45 64 30, anja.bisgaard.pinborg@regionh.dk
Clara Colombo, MD, clara.colombo@regionh.dk
About this study
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.
Read the 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.
Participants will have a visit on cycle day 2-4 of the first period after oocyte retrieval where baseline characteristics will be assessed. Patients start treatment according to the randomization, thus women in the FET immediate group will start FET immediately whereas women randomized to postponed FET will wait for at least one cycle (natural or induced by sequential estradiol-Provera treatment in oligo-anovulatory women).
SC-FET: Patients undergoing stimulated cycle FET will start the mild ovarian stimulation with either letrozole 5 mg (2,5) daily for five days starting on cd 3-5, or with gonadotropins hMG/rFSH 50-75 IE daily (initial dose may be higher if needed based on previous treatments). Ovulation trigger (hCG) are administered when the leading follicle reaches ≥18 mm (letrozole) or ≥17 mm (gonadotropin). Blastocyst transfer will be performed 6-7 days after trigger.
PC-FET: Patients undergoing PC FET will start treatment with estradiol 6 mg/day from cycle day 3-5, and after 10-12 days an ultrasound scan will be performed. If the endometrial thickness is <7 mm, plasma levels of estradiol can be measured and additional estradiol is added according to local clinical practice. After another 4-6 days a new ultrasound scan is performed and progesterone supplementation will be added no matter of the endometrial thickness and blastocyst transfer will be performed on the 5th or the 6th day of progesterone supplementation.
Blood samples will be drawn on the baseline visit (all patients), on cycle day 2-4 in the postponed FET group, on the day of hCG trigger (SC) or on progesterone supplementation day 10-12 (PC), on the day the blastocyst transfer, and on the day of pregnancy testing.
In case of pregnancy, pregnancy and delivery data will be collected from the patients medical records and the new borns birth record. This will be done in accordance to an informed consent form, which is signed by the participants at inclusion.
The primary outcome of the study will be live birth rates (LBR). Secondary outcomes include 1) LBR per blastocyst transfer 2) Clinical pregnancy rate (CPR) 3) ongoing pregnancy rate (OPR) 4) miscarriage rate (MR) 5) cancelled cycle rate including reason for cycle cancellation 6) endocrinology of the luteal phase by means of hormone levels at predefined time-points 7) number of ovarian follicular structures >10 mm at cycle day 2-5 of the treatment cycle and on the first day of progesterone supplementation 8) time to pregnancy and live birth from start of ovarian stimulation in the fresh cycle.
Pregnancy related complications, such as preeclampsia, pregnancy related hypertension, medically assisted delivery and postpartum hemorrhage (>100 mL), and neonatal outcomes including preterm birth, low birth weight, small or large for gestational age and perinatal mortality, will also be assessed and compared between groups.
An interim analysis will be performed after inclusion of the first 150 patients (n=75 in each group). The mean number of scans will be compared between the two groups. This will be done to evaluate if the mean number of ultrasoundsscans in the intervention group exceeds that of the control group by more than two scans, if this is the case we will consider terminating the trial.
- Conditions
- Infertility, IVF
- Being tested
- Immediate FET in a stimulated or programmed cycle
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate FET in a stimulated or programmed cycleProcedure or surgery
Patients will undergo FET in the cycle immediately following oocyte retrieval and a failed fresh embryo transfer or freeze all.
| Study group | Role | What they receive |
|---|---|---|
| Immediate FET in a stimulated or programmed cycle | Experimental | Stimulated or programmed cycle FET is performed in the first cycle following failed fresh embryo transfer or freeze all. Receives: Procedure: Immediate FET in a stimulated or programmed cycle |
| Postponed FET in a stimulated or programmed cycle | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Live birth rate in immediate FET compared to postponed FET in women undergoing FET in a stimulated or programmed cycle.
Measured: One year follow up from positive pregnancy test.
Secondary outcomes (13)
Live birth rate per blastocyst transfer
Live birth rate overall in both groups
Measured: One year follow up from positive pregnancy test.
Ongoing pregnancy rate
Ongoing pregnancy rate where pregnancy is assessed by ultrasound in the immediate versus the postponed group
Measured: At 7 or 8 weeks of gestation in case of pregnancy
Miscarriage rate
Rate of pregnancy loss in the immediate versus the postponed group
Measured: Until 22 weeks of gestation in women with positive pregnancy test
Cancelled cycle rate and reason for cancelled cycles
Cancelled cycle rate in the immediate versus the postponed group
Measured: Will be assessed through study participation dependent on the participants cycle up to 50 days
Endocrinology of the luteal phase
Hormone levels at predefined time-points in the immediate versus the postponed group
Measured: Through each participants cycle, will be dependent on participants cycle up to 50 days
Number of ovarian follicular structures >10 mm
Number of ovarian follicular structures >10 mm in the immediate versus postponed arm
Measured: Twice through the cycle, dependent on participants cycle length up to 50 days
Time-to-pregnancy
Time-to-pregnancy in the immediate versus postponed arm
Measured: From day of ovarian stimulation until clinical pregnancy dependent on participants cycle length up to 70 days
Time-to-live-birth
Time-to-live-birth in the immediate versus postponed arm
Measured: From day of ovarian stimulation through study completion up to 1 year
Pregnancy related complications
Pregnancy related complications in patients receiving immediate versus postponed FET
Measured: One year follow up from positive pregnancy test
Neonatal outcomes (weight in kilograms)
Neonatal outcome in children of patients in patients receiving immediate versus postponed FET
Measured: One year follow up from positive pregnancy test
Neonatal outcomes (length in cm)
Neonatal outcome in children of patients in patients receiving immediate versus postponed FET
Measured: One year follow up from positive pregnancy test
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.
Measured: One year follow up from positive pregnancy test
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".
Measured: Questionnaires will be handed out at baseline and after blastocyst transfer timeframe will depend on the participants cycle up to 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Feb 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Bisgaard Pinborg, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304792
- Sponsor's protocol ID
- H-22030591
- Status last verified
- Aug 2025
- First submitted
- 23 Feb 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In case of requests, the final data will be shared according to the ICJME guidelines. Sharing will only be done with parties presenting new research projects which have been approved by the steering committee of the research team. Any new project involving data collected in this trial must also be approved by Danish authorities. Expenses for data sharing will be covered by those requesting it. Data will not be shared with research groups conducting projects with the same aim, secondary aims and/or purposes as ours until three months after publication of the primary and secondary outcomes of this study.
Publications
Colombo C, Johansen AS, Saupstad M, Bergenheim SJ, Dam TV, Wang NF, Oxlund-Mariegaard B, Lokkegaard E, Husth M, Lauritsen MP, Forman JL, Freiesleben NC, Nohr B, Lossl K, Pinborg A. Immediate versus postponed blastocyst transfer in stimulated or programmed frozen embryo transfer cycles - a protocol for a non-blinded randomised clinical trial. Dan Med J. 2025 Jul 22;72(8):A03250214. doi: 10.61409/A03250214.
PubMed 40747727
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06304792
- Acronym / sponsor ID
- H-22030591
- Conditions
- Infertility, IVF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Participants will have a visit on cycle day 2-4 of the first period after oocyte retrieval where baseline characteristics will be assessed. Patients start treatment according to the randomization, thus women in the FET immediate group will start FET immediately whereas women randomized to postponed FET will wait for at least one cycle (natural or induced by sequential estradiol-Provera treatment in oligo-anovulatory women).
SC-FET: Patients undergoing stimulated cycle FET will start the mild ovarian stimulation with either letrozole 5 mg (2,5) daily for five days starting on cd 3-5, or with gonadotropins hMG/rFSH 50-75 IE daily (initial dose may be higher if needed based on previous treatments). Ovulation trigger (hCG) are administered when the leading follicle reaches ≥18 mm (letrozole) or ≥17 mm (gonadotropin). Blastocyst transfer will be performed 6-7 days after trigger.
PC-FET: Patients undergoing PC FET will start treatment with estradiol 6 mg/day from cycle day 3-5, and after 10-12 days an ultrasound scan will be performed. If the endometrial thickness is <7 mm, plasma levels of estradiol can be measured and additional estradiol is added according to local clinical practice. After another 4-6 days a new ultrasound scan is performed and progesterone supplementation will be added no matter of the endometrial thickness and blastocyst transfer will be performed on the 5th or the 6th day of progesterone supplementation.
Blood samples will be drawn on the baseline visit (all patients), on cycle day 2-4 in the postponed FET group, on the day of hCG trigger (SC) or on progesterone supplementation day 10-12 (PC), on the day the blastocyst transfer, and on the day of pregnancy testing.
In case of pregnancy, pregnancy and delivery data will be collected from the patients medical records and the new borns birth record. This will be done in accordance to an informed consent form, which is signed by the participants at inclusion.
The primary outcome of the study will be live birth rates (LBR). Secondary outcomes include 1) LBR per blastocyst transfer 2) Clinical pregnancy rate (CPR) 3) ongoing pregnancy rate (OPR) 4) miscarriage rate (MR) 5) cancelled cycle rate including reason for cycle cancellation 6) endocrinology of the luteal phase by means of hormone levels at predefined time-points 7) number of ovarian follicular structures >10 mm at cycle day 2-5 of the treatment cycle and on the first day of progesterone supplementation 8) time to pregnancy and live birth from start of ovarian stimulation in the fresh cycle.
Pregnancy related complications, such as preeclampsia, pregnancy related hypertension, medically assisted delivery and postpartum hemorrhage (>100 mL), and neonatal outcomes including preterm birth, low birth weight, small or large for gestational age and perinatal mortality, will also be assessed and compared between groups.
An interim analysis will be performed after inclusion of the first 150 patients (n=75 in each group). The mean number of scans will be compared between the two groups. This will be done to evaluate if the mean number of ultrasoundsscans in the intervention group exceeds that of the control group by more than two scans, if this is the case we will consider terminating the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate FET in a stimulated or programmed cycle | Experimental | Procedure: Immediate FET in a stimulated or programmed cycleStimulated or programmed cycle FET is performed in the first cycle following failed fresh embryo transfer or freeze all. |
| Postponed FET in a stimulated or programmed cycle | No intervention | –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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate FET in a stimulated or programmed cyclePatients will undergo FET in the cycle immediately following oocyte retrieval and a failed fresh embryo transfer or freeze all. | Procedure or surgery | Immediate FET in a stimulated or programmed cycle |
Primary outcome
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.
13 secondary outcomes
Live birth rate per blastocyst transfer
Time frame: One year follow up from positive pregnancy test.
Ongoing pregnancy rate
Time frame: At 7 or 8 weeks of gestation in case of pregnancy
Miscarriage rate
Time frame: Until 22 weeks of gestation in women with positive pregnancy test
Cancelled cycle rate and reason for cancelled cycles
Time frame: Will be assessed through study participation dependent on the participants cycle up to 50 days
Endocrinology of the luteal phase
Time frame: Through each participants cycle, will be dependent on participants cycle up to 50 days
Number of ovarian follicular structures >10 mm
Time frame: Twice through the cycle, dependent on participants cycle length up to 50 days
Time-to-pregnancy
Time frame: From day of ovarian stimulation until clinical pregnancy dependent on participants cycle length up to 70 days
Time-to-live-birth
Time frame: From day of ovarian stimulation through study completion up to 1 year
Pregnancy related complications
Time frame: One year follow up from positive pregnancy test
Neonatal outcomes (weight in kilograms)
Time frame: One year follow up from positive pregnancy test
Neonatal outcomes (length in cm)
Time frame: One year follow up from positive pregnancy test
Neonatal outcomes (apgar score at 1, 5 and 10 minutes postpartum)
Time frame: One year follow up from positive pregnancy test
Quality of life based on the Copenhagen Multicenter Psychosocial Infertility (COMPI) stress scale questionnaires
Time frame: Questionnaires will be handed out at baseline and after blastocyst transfer timeframe will depend on the participants cycle up to 50 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 40747727Colombo C, Johansen AS, Saupstad M, Bergenheim SJ, Dam TV, Wang NF, Oxlund-Mariegaard B, Lokkegaard E, Husth M, Lauritsen MP, Forman JL, Freiesleben NC, Nohr B, Lossl K, Pinborg A. Immediate versus postponed blastocyst transfer in stimulated or programmed frozen embryo transfer cycles - a protocol for a non-blinded randomised clinical trial. Dan Med J. 2025 Jul 22;72(8):A03250214. doi: 10.61409/A03250214.
- Individual participant dataSharing planned: Yes. In case of requests, the final data will be shared according to the ICJME guidelines. Sharing will only be done with parties presenting new research projects which have been approved by the steering committee of the research team. Any new project involving data collected in this trial must also be approved by Danish authorities. Expenses for data sharing will be covered by those requesting it. Data will not be shared with research groups conducting projects with the same aim, secondary aims and/or purposes as ours until three months after publication of the primary and secondary outcomes of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate FET in a stimulated or programmed cycle in people with Infertility and IVF, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anja B Pinborg, Prof., DMSC (0045 35 45 64 30, anja.bisgaard.pinborg@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: One year follow up from positive pregnancy test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06304792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.