- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06304792
Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer
Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer: a Multicenter Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 464 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 3-4, 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 (Cyclogest 400 mg x 2-3 daily) 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anja B Pinborg, Prof., DMSC
- Phone Number: 0045 35 45 64 30
- Email: anja.bisgaard.pinborg@regionh.dk
Study Locations
-
-
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Copenhagen, Denmark, 2100
- Recruiting
- Fertility Departmen, Rigshospitalet
-
Contact:
- Anja B. Pinborg, Prof., DMSC
- Phone Number: 0045 35 45 64 30
- Email: anja.bisgaard.pinborg@regionh.dk
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Contact:
- Clara Colombo, MD
- Email: clara.colombo@regionh.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Patients will undergo FET in the cycle immediately following oocyte retrieval and a failed fresh embryo transfer or freeze all.
|
No Intervention: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One year follow up from positive pregnancy test.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Live birth rate per blastocyst transfer
Time Frame: One year follow up from positive pregnancy test.
|
Live birth rate overall in both groups
|
One year follow up from positive pregnancy test.
|
Ongoing pregnancy rate
Time Frame: At 7 or 8 weeks of gestation in case of pregnancy
|
Ongoing pregnancy rate where pregnancy is assessed by ultrasound in the immediate versus the postponed group
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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
|
Rate of pregnancy loss in the immediate versus the postponed group
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Until 22 weeks of gestation in women with positive pregnancy test
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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
|
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
|
Endocrinology of the luteal phase
Time Frame: Through each participants cycle, will be dependent on participants cycle up to 50 days
|
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
|
Number of ovarian follicular structures >10 mm
Time Frame: Twice through the cycle, dependent on participants cycle length up to 50 days
|
Number of ovarian follicular structures >10 mm in the immediate versus postponed arm
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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
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Time-to-pregnancy in the immediate versus postponed arm
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From day of ovarian stimulation until clinical pregnancy dependent on participants cycle length up to 70 days
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Time-to-live-birth
Time Frame: From day of ovarian stimulation through study completion up to 1 year
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Time-to-live-birth in the immediate versus postponed arm
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From day of ovarian stimulation through study completion up to 1 year
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Pregnancy related complications
Time Frame: One year follow up from positive pregnancy test
|
Pregnancy related complications in patients receiving immediate versus postponed FET
|
One year follow up from positive pregnancy test
|
Neonatal outcomes (weight in kilograms)
Time Frame: One year follow up from positive pregnancy test
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Neonatal outcome in children of patients in patients receiving immediate versus postponed FET
|
One year follow up from positive pregnancy test
|
Neonatal outcomes (length in cm)
Time Frame: One year follow up from positive pregnancy test
|
Neonatal outcome in children of patients in patients receiving immediate versus postponed FET
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One year follow up from positive pregnancy test
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Neonatal outcomes (apgar score at 1, 5 and 10 minutes postpartum)
Time Frame: One year follow up from positive pregnancy test
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Neonatal outcome in children of patients in patients receiving immediate versus postponed FET
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One year follow up from positive pregnancy test
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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
|
Quality of life in the immediate versus postponed arm
|
Questionnaires will be handed out at baseline and after blastocyst transfer timeframe will depend on the participants cycle up to 50 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-22030591
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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