Impact du compactage de l'endomètre sur les résultats de la reproduction après cryotransfert d'embryons euploïdes dans un cycle naturel (Compaction)
Impact du compactage de l'endomètre sur les résultats de la reproduction après cryotransfert d'embryons euploïdes dans un cycle naturel : étude de cohorte prospective
Multicenter prospective observational cohort study, comparing ongoing pregnancy rates in natural cycles for euploid embryo transfer in patients who present endometrial compaction at the time of the transfer versus those who have a stable or greater endometrial thickness with respect to the estrogenic phase.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Multicenter prospective observational cohort study. Based on our sample size calculation, the study group will consist of 206 women (exposed or "compaction" group: 103 women with a decrease of ≥ 5% in endometrial thickness between the estrogenic phase and the day of embryo transfer; non-exposed "non-compaction" group: 103 women with similar or greater endometrial thickness between these time points). The main objective of this study is to compare the ongoing pregnancy rates in natural cycles for euploid embryo transfer in patients who present endometrial compaction at the time of transfer versus those who with a stable or greater endometrial thickness with respect to the estrogenic phase. The estimated duration of the study is 24-30 months. Inclusion criteria are: 18 to 50 years of age, with primary or secondary infertility, subjected to endometrial preparation in a modified natural cycle for transfer of a genetically euploid blastocyst, from their own oocyte or oocyte donation, with a normal uterine cavity. Exclusion criteria are: uterine or endometrial disease (e.g., multiple myomatosis, severe adenomyosis, Asherman syndrome, refractory endometrium), conditions that prevent correct ultrasound assessment (tilted uterus), or a history of recurrent implantation failure or repeated miscarriages.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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-
Madrid
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Madrid, Madrid, Espagne, 28001
- Instituto Bernabeu
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
206 Women between 18-50 years, with primary or secondary infertility, undergoing fertility treatment that includes endometrial preparation in a modified natural cycle for transfer of previously analyzed frozen and euploid embryos.
La description
Inclusion Criteria:
- Aged 18 to 50 years
- Primary or secondary infertility
- Normal uterine cavity
- Endometrial preparation in a modified natural cycle for single embryo transfer
- Embryo in blastocyst state from own oocyte or oocyte donation cycles, who had normal results on preimplantation genetic testing for aneuploidy (PGT-A) via trophectoderm biopsy.
Exclusion Criteria:
- Uterine or endometrial disease (multiple myomatosis [>3 fibroids of > 3 cm], adenomyosis, Asherman syndrome)
- Difficulties in correctly measuring endometrial thickness due to a retroverted or tilted uterus
- History of recurrent implantation failure (3 or more transferred blastocysts of good quality, from their own oocyte [<35 years] or oocyte donation); recurrent early Pregnancy Loss (the loss of two or more pregnancies before 10 weeks of gestational age.
- Suboptimal endometrial response (endometrium < 6 mm on the day of ovulation triggering).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
exposed or "compaction" group
103 women with a decrease of ≥ 5% in endometrial thickness between the estrogenic phase (ovulation induction day) and the day of embryo transfer (7 days after ovulation induction). |
An additional control scan will be performed vaginally the day of the embryo transfer. Rest of follow up and treatment will be executed as usually. |
|
non-exposed "non-compaction" group
103 women with similar or greater endometrial thickness between the estrogenic phase (ovulation induction day) and the day of embryo transfer (7 days after ovulation induction). |
An additional control scan will be performed vaginally the day of the embryo transfer. Rest of follow up and treatment will be executed as usually. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Ongoing pregnancy rate
Délai: 8-10 weeks gestational age.
|
Presence of an intrauterine pregnancy with positive embryo heartbeat as seen by sonography at 8-10 weeks gestational age. |
8-10 weeks gestational age.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Biochemical pregnancy loss
Délai: 9-10 days after the embryo transfer.
|
Spontaneous pregnancy demise based on decreasing serum b-hCG levels, without an ultrasound evaluation. |
9-10 days after the embryo transfer.
|
|
Clinical pregnancy
Délai: 5-6 weeks gestational age.
|
A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. |
5-6 weeks gestational age.
|
|
Ectopic pregnancy
Délai: 5-8 weeks gestational age.
|
ultrasonic or surgical visualization of a pregnancy outside of the endometrial cavity. |
5-8 weeks gestational age.
|
|
Early pregnancy loss
Délai: 5-10 weeks gestational age.
|
spontaneous pregnancy demise before 10 weeks of gestational age (before 8th developmental week). |
5-10 weeks gestational age.
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Juan Carlos J Castillo Farfan, Doctor, Instituto Bernabeu Alicante
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Compaction Study
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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