Advantages of Early Intrauterine Transfer of "Blank" Culture Medium Prior to 1st or 2nd Transfer of Thawed Embryo(s).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blank culture transfer, Sham transfer.
- Who it may be relevant to
- Registry conditions: Single Embryo Transfer, Fertilization in Vitro. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Reunion
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Procedure Blank culture 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 - Procedure Sham transfer
An intermediate transfer step is added two or three days before the planned transfer of the frozen embryo but with an empty catheter.
Primary outcome measures
- Clinically progressive pregnancy rate between groups [Time frame: 12 weeks of amenorrhea]
Secondary outcome measures (7)
- 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)]
Eligibility criteria
Inclusion criteria
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
France · 6 centers
- Hôpital Antoine Béclère — Clamart
- Centre Hospitalier Alpes Léman — Contamine-sur-Arve
- CHU Arnaud de Villeneuve — Montpellier
- Clinique Saint Roch — Montpellier
- CHU de Nîmes — Nîmes
- Clinique Saint-Pierre — Perpignan
Reunion · 1 center
- CHU de la Réunion — Saint-Pierre
Identifiers
NCT: NCT06177613 · PHRC-I/2022/NR-01