Single Embryo TransferTRABLANNCT06177613
Advantages of Early Intrauterine Transfer of "Blank" Culture Medium Prior to 1st or 2nd Transfer of Thawed Embryo(s).
A study testing Blank culture transfer in people with Single Embryo Transfer and Fertilization in Vitro, run by Centre Hospitalier Universitaire de Nīmes at 7 sites in 2 countries.
Trial summary
Despite technical advances in Medically Assisted Reproduction (AMP), the success of fertility treatments is sometimes limited by embryo implantation failure. The coordinated development of the embryo and the uterine endometrium requires close communication between the maternal tissue and the embryo. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Single Embryo Transfer, Fertilization in Vitro
- What is being tested?
- Blank culture transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,154 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 9 Feb 2024to Feb 2027
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Having had a first "fresh" or frozen embryo transfer, whatever the embryo's stage of development, transfer followed by pregnancy failure ;
- Frozen embryos must be at least D3 stage;
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Who cannot join
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The patient is under safeguard of justice or state guardianship
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
France6 sites, 6 recruiting
- Not yet recruiting
Hôpital Antoine Béclère
Clamart
Michaël Grynberg, michael.grynberg@aphp.fr
Michaël Grynberg
- Not yet recruiting
Centre Hospitalier Alpes Léman
Contamine-sur-Arve
Béatrice Dorphin, beatrice.dorphin@biogroup.fr
Béatrice Dorphin
- Not yet recruiting
CHU Arnaud de Villeneuve
Montpellier
Noémie Ranisavljevic, n-ranisavljevic@chu-montpellier.fr
Noémie Ranisavljevic
- Not yet recruiting
Clinique Saint Roch
Montpellier
Olivier Pouget, pouget@abcgyneco.fr
- Recruiting
CHU de Nîmes
Nîmes, 30029
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Nathalie Rougier
- Not yet recruiting
Clinique Saint-Pierre
Perpignan
Emmanuelle Petit, emmapetit@gmail.com
Emmanuelle Petit
Reunion1 site, 1 recruiting
- Not yet recruiting
CHU de la Réunion
Saint-Pierre
Helene Flye Sainte Marie, helene.flye@chu-reunion.fr
Helene Flye Sainte Marie
About this study
Official title: Advantages of Early Intrauterine Transfer of "Blank" Culture Medium Prior to 1st or 2nd Transfer of Thawed Embryo(s). Randomized, Single-blind, Multicenter Controlled Trial.
Despite technical advances in Medically Assisted Reproduction (AMP), the success of fertility treatments is sometimes limited by embryo implantation failure. The coordinated development of the embryo and the uterine endometrium requires close communication between the maternal tissue and the embryo. In in vitro fertilization (IVF), embryo transfer generally takes place between the 2nd (D2) and the 6th (D6) day following oocyte fertilization. Recent studies have shown the advantages of sequential transfer (transfer of an embryo on D2/D3 followed by the transfer of another embryo on D5/D6), with higher implantation and clinical pregnancy rate, fewer miscarriages, more live births, and yet no increase in multiple pregnancies. However, the American Society for Reproductive Medicine recommendations continue to prioritize the transfer of a single embryo for all patients aged under 38. To improve pregnancy rates for patients having a single embryo transferred, the study investigators wish to carry out on "blank" transfer, based on the principle of sequential transfer. The study investigators hypothesize that a culture medium, placed in the uterus before the time of embryo transfer, will modify immune tolerance. The study will test whether transferring the same culture medium in an equivalent quantity as during the real transfer into the uterus 2/3 days before the embryo transfer will improve tolerance to this foreign medium and, therefore, embryo implantation. The aim of this study is thus to evaluate the impact of a "blank" transfer with culture medium alone, on the results of frozen embryo transfers (FET) from IVF.
- Conditions
- Single Embryo Transfer, Fertilization in Vitro
- Being tested
- Blank culture transfer, Sham transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blank culture transferProcedure or surgery
A maximum of 0.1 ml of gassed embryo culture medium preheated to 37°C is injected into the uterine cavity transcervically using an embryo transfer catheter placed just beyond the internal os, two to 3 days before transfer of the thawed embryo
Sham transferProcedure or surgery
An intermediate transfer step is added two or three days before the planned transfer of the frozen embryo but with an empty catheter.
| Study group | Role | What they receive |
|---|---|---|
| With blank culture | Experimental | Not described Receives: Procedure: Blank culture transfer |
| Without blank culture | Sham comparator | Not described Receives: Procedure: Sham transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically progressive pregnancy rate between groups
Measured on first-trimester ultrasound
Measured: 12 weeks of amenorrhea
Secondary outcomes (7)
Occurrence of pregnancy between groups
Defined by a positive beta HCG test ≥ 100 IU/ml
Measured: Day 14
Occurrence of a biochemical pregnancy between groups
Defined by a positive beta HCG test ≥ 10 IU/ml and < 100 IU/ml
Measured: Day 14
Occurrence of a clinical pregnancy between groups
Defined by a positive beta HCG test ≥ 100 IU/ml and presence of at least one gestational sac on dating ultrasound
Measured: 6 weeks of amenorrhea
Occurrence of an early miscarriage between groups
Defined by the presence of a pregnancy defined by a positive beta HCG test ≥ 100 IU at D14 and the absence of an evolving clinical pregnancy at first-trimester ultrasound
Measured: 12 weeks of amenorrhea
Occurrence of live birth
Yes/no
Measured: Upon giving birth (maximum month 9)
Differential cost-result ratio
Ratio of the cost differential and the number of additional live births (additional progressive clinical pregnancies) between the two strategies, to evaluate the cost per additional live birth.
Measured: End of study (Year 3)
Total estimated expenditure for the two care strategies compared (budget impact analysis) over a one-year time horizon.
Calculated at national level (implementation of the system and consumption of care)
Measured: End of study (Year 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start9 Feb 2024
- Primary completionMay 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Embryo TransferStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Rougier, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177613
- Sponsor's protocol ID
- PHRC-I/2022/NR-01
- Acronym
- TRABLAN
- Status last verified
- Feb 2025
- First submitted
- 11 Dec 2023
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advantages of Early Intrauterine Transfer of "Blank" Culture Medium Prior to 1st or 2nd Transfer of Thawed Embryo(s). Randomized, Single-blind, Multicenter Controlled Trial.
- ClinicalTrials.gov ID
- NCT06177613
- Acronym / sponsor ID
- TRABLAN / PHRC-I/2022/NR-01
- Conditions
- Single Embryo Transfer, Fertilization in Vitro
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,154 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Dec 2023 (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.
Despite technical advances in Medically Assisted Reproduction (AMP), the success of fertility treatments is sometimes limited by embryo implantation failure. The coordinated development of the embryo and the uterine endometrium requires close communication between the maternal tissue and the embryo. In in vitro fertilization (IVF), embryo transfer generally takes place between the 2nd (D2) and the 6th (D6) day following oocyte fertilization. Recent studies have shown the advantages of sequential transfer (transfer of an embryo on D2/D3 followed by the transfer of another embryo on D5/D6), with higher implantation and clinical pregnancy rate, fewer miscarriages, more live births, and yet no increase in multiple pregnancies. However, the American Society for Reproductive Medicine recommendations continue to prioritize the transfer of a single embryo for all patients aged under 38. To improve pregnancy rates for patients having a single embryo transferred, the study investigators wish to carry out on "blank" transfer, based on the principle of sequential transfer. The study investigators hypothesize that a culture medium, placed in the uterus before the time of embryo transfer, will modify immune tolerance. The study will test whether transferring the same culture medium in an equivalent quantity as during the real transfer into the uterus 2/3 days before the embryo transfer will improve tolerance to this foreign medium and, therefore, embryo implantation. The aim of this study is thus to evaluate the impact of a "blank" transfer with culture medium alone, on the results of frozen embryo transfers (FET) from IVF.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With blank culture | Experimental | Procedure: Blank culture transfer |
| Without blank culture | Sham comparator | Procedure: Sham transfer |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Having had a first "fresh" or frozen embryo transfer, whatever the embryo's stage of development, transfer followed by pregnancy failure ;
- Frozen embryos must be at least D3 stage;
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Key exclusion criteria (2 listed)
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The patient is under safeguard of justice or state guardianship
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 |
|---|---|---|
| Blank culture transferA maximum of 0.1 ml of gassed embryo culture medium preheated to 37°C is injected into the uterine cavity transcervically using an embryo transfer catheter placed just beyond the internal os, two to 3 days before transfer of the thawed embryo | Procedure or surgery | With blank culture |
| Sham transferAn intermediate transfer step is added two or three days before the planned transfer of the frozen embryo but with an empty catheter. | Procedure or surgery | Without blank culture |
Primary outcome
Clinically progressive pregnancy rate between groups
Time frame: 12 weeks of amenorrhea
Measured on first-trimester ultrasound
7 secondary outcomes
Occurrence of pregnancy between groups
Time frame: Day 14
Occurrence of a biochemical pregnancy between groups
Time frame: Day 14
Occurrence of a clinical pregnancy between groups
Time frame: 6 weeks of amenorrhea
Occurrence of an early miscarriage between groups
Time frame: 12 weeks of amenorrhea
Occurrence of live birth
Time frame: Upon giving birth (maximum month 9)
Differential cost-result ratio
Time frame: End of study (Year 3)
Total estimated expenditure for the two care strategies compared (budget impact analysis) over a one-year time horizon.
Time frame: End of study (Year 3)
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 20 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Single Embryo Transfer
Not yet recruitingObservational study
Correlation Of Clinical Outcomes After Transfer Of Good-Quality Morphology Embryos In Patients With A Favorable Prognosis And Non-Invasive Preimplantation Genetic Testing For Aneuploidy (NiPGT-A) Results
Infertility (IVF Patients), Clinical Pregnancy After Single Embryo Transfer
Not yet recruitingObservational study
Impact of Uterine Immune Profiling and Personalized Treatments in Patients Receiving a Single Blastocyst: a Matched Controlled Study
Infertility, Success Rate of Assisted Reproductive Therapy
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.
Nathalie Rougier principal investigator
CHU de Nimes
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blank culture transfer in people with Single Embryo Transfer and Fertilization in Vitro, run by Centre Hospitalier Universitaire de Nīmes at 7 sites in 2 countries.
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 2 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Reunion. 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. Some participants in this study may receive a placebo. 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 Nathalie Rougier (04.66.68.32.24, nathalie.rougier@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically progressive pregnancy rate between groups (time frame: 12 weeks of amenorrhea). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.