An interventional study of Blank culture transfer and Sham transfer in Single Embryo Transfer and Fertilization in Vitro, sponsored by Centre Hospitalier Universitaire de Nīmes. Recruiting at 7 sites in 2 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Other
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.
Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Blank culture transfer
Procedure: Sham transfer
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
An intermediate transfer step is added two or three days before the planned transfer of the frozen embryo but with an empty catheter.
Clinically progressive pregnancy rate between groups
Measured on first-trimester ultrasound
Time frame: 12 weeks of amenorrhea
Occurrence of pregnancy between groups
Defined by a positive beta HCG test ≥ 100 IU/ml
Time frame: Day 14
Occurrence of a biochemical pregnancy between groups
Defined by a positive beta HCG test ≥ 10 IU/ml and \< 100 IU/ml
Time frame: 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
Time frame: 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
Time frame: 12 weeks of amenorrhea
Occurrence of live birth
Yes/no
Time frame: 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.
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.
Calculated at national level (implementation of the system and consumption of care)
Time frame: End of study (Year 3)
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Universitaire de Nīmes →