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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With blank culture | Experimental |
| |
| Without blank culture | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blank culture transfer | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically progressive pregnancy rate between groups | Measured on first-trimester ultrasound | 12 weeks of amenorrhea |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of pregnancy between groups | Defined by a positive beta HCG test ≥ 100 IU/ml | Day 14 |
| Occurrence of a biochemical pregnancy between groups | Defined by a positive beta HCG test ≥ 10 IU/ml and < 100 IU/ml |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie Rougier | Contact | 04.66.68.32.24 | nathalie.rougier@chu-nimes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie Rougier | CHU de Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Antoine Béclère | Not yet recruiting | Clamart | France |
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| Sham transfer | Procedure | An intermediate transfer step is added two or three days before the planned transfer of the frozen embryo but with an empty catheter. |
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| 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 | 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 | 12 weeks of amenorrhea |
| Occurrence of live birth | Yes/no | 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. | 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) | End of study (Year 3) |
| Centre Hospitalier Alpes Léman | Not yet recruiting | Contamine-sur-Arve | France |
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| CHU Arnaud de Villeneuve | Not yet recruiting | Montpellier | France |
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| Clinique Saint Roch | Not yet recruiting | Montpellier | France |
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| CHU de Nîmes | Recruiting | Nîmes | 30029 | France |
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| Clinique Saint-Pierre | Not yet recruiting | Perpignan | France |
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| CHU de la Réunion | Not yet recruiting | Saint-Pierre | Reunion |
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