Fertilization in Vitro Clinical Trial
— TRABLANOfficial title:
Benefit of Early Intrauterine Transfer of "Blank" Culture Medium Prior to Transfer of a Thawed Embryo From 1st in Vitro Fertilization - 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.
Status | Recruiting |
Enrollment | 1154 |
Est. completion date | February 2027 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 39 Years |
Eligibility | Inclusion Criteria: - Having had a first "fresh" or frozen embryo transfer, whatever the embryo's stage of development, transfer followed by pregnancy failure ; - Having at least two embryos eligible for transfer or freezing during a 1st IVF attempt (one fresh + one frozen or two frozen); - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Antoine Béclère | Clamart | |
France | Centre Hospitalier Alpes Léman | Contamine-sur-Arve | |
France | CHU Arnaud de Villeneuve | Montpellier | |
France | Clinique Saint Roch | Montpellier | |
France | CHU de Nîmes | Nîmes | |
France | Clinique Saint-Pierre | Perpignan | |
Réunion | CHU de la Réunion | Saint-Pierre |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France, Réunion,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinically progressive pregnancy rate between groups | Measured on first-trimester ultrasound | 12 weeks of amenorrhea | |
Secondary | Occurrence of pregnancy between groups | Defined by a positive beta HCG test = 100 IU/ml | Day 14 | |
Secondary | Occurrence of a biochemical pregnancy between groups | Defined by a positive beta HCG test = 10 IU/ml and < 100 IU/ml | Day 14 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Occurrence of live birth | Yes/no | Upon giving birth (maximum month 9) | |
Secondary | 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) | |
Secondary | 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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04213781 -
Interest of Audiovisual Distraction in the Management of Anxiety and Pain During Oocyte Retrieval
|
N/A | |
Completed |
NCT00608010 -
Day 3 Embryo Cryopreservation: Metabolic and Viability Analysis
|
N/A | |
Completed |
NCT03527823 -
The Comparison of Granulosa Cell Apoptosis Rates With or Without Luteinizing Hormone Administration in Poor Responders.
|
||
Terminated |
NCT02990949 -
The Impact of the Timing of Trigger on IVF Success
|
N/A | |
Not yet recruiting |
NCT02971280 -
Influence of Heavy Metals Exposure on in Vitro Fertilization (IVF) Outcome
|
N/A | |
Completed |
NCT00920361 -
Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)
|
||
Recruiting |
NCT06134609 -
Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer?
|
N/A | |
Completed |
NCT03238833 -
Poor Ovarian Responders Undergoing IVF Using Luteal Ovarian Stimulation Versus Follicular Ovarian Stimulation
|
N/A | |
Withdrawn |
NCT03062098 -
Optimizing the Technique of Embryo Transfer in IVF Using Better Imaging Guidance
|
N/A | |
Recruiting |
NCT06410417 -
Ejaculation Abstinence Time and Assisted Reproductive Technology Outcomes
|
N/A | |
Not yet recruiting |
NCT06385444 -
IVF Failure and Pregnancy Loss on Couples' Psychological Stress
|
||
Recruiting |
NCT03700255 -
Efficacy of a Simulator Based (PickUpSimTM) Residents' Training Program for Oocyte Retrievals
|
N/A | |
Recruiting |
NCT04935658 -
Oocyte Retrieval and Virtual Reality (REVPO)
|
N/A | |
Recruiting |
NCT03713723 -
Cardiac Output Monitoring in IVF Patients
|
||
Completed |
NCT03733912 -
Plasticizers and in Vitro Fertilization Outcomes
|
||
Not yet recruiting |
NCT06433518 -
BEst Size for Ovulation Triggering in Poseidon 4 Patients (BEST 4 Study)
|
||
Completed |
NCT02323347 -
Cut-Off Progesterone Values Deleterious for In Vitro Fertilization and Fresh Embryo Transfer
|
N/A | |
Completed |
NCT00750451 -
Low Molecular Weight Heparin in Recurrent Implantation Failure
|
N/A | |
Recruiting |
NCT04124913 -
Oral Dydrogesterone vs. Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles
|
Phase 4 | |
Completed |
NCT04755270 -
Virtual Reality-Supported Hypnofertility
|
N/A |