Indvirkning af endometriekomprimering på reproduktive resultater efter kryooverførsel af euploide embryoner i en naturlig cyklus (Compaction)
Indvirkning af endometriekomprimering på reproduktive resultater efter kryooverførsel af euploide embryoner i en naturlig cyklus: Prospektiv kohorteundersøgelse
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Madrid
-
Madrid, Madrid, Spanien, 28001
- Instituto Bernabeu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ongoing pregnancy rate
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Biochemical pregnancy loss
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 5-10 weeks gestational age.
|
spontaneous pregnancy demise before 10 weeks of gestational age (before 8th developmental week). |
5-10 weeks gestational age.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Juan Carlos J Castillo Farfan, Doctor, Instituto Bernabeu Alicante
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Compaction Study
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .