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| Name | Class |
|---|---|
| Universidad Miguel Hernandez de Elche | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational non intervention study | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy rate | Presence of an intrauterine pregnancy with positive embryo heartbeat as seen by sonography at 8-10 weeks gestational age. | 8-10 weeks gestational age. |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical pregnancy loss | Spontaneous pregnancy demise based on decreasing serum b-hCG levels, without an ultrasound evaluation. | 9-10 days after the embryo transfer. |
| Clinical pregnancy | A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. |
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Inclusion Criteria:
Exclusion Criteria:
Women undergoing fertility treatment.
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esperanza E de la Torre Pérez, Gynecologist | Contact | +34625072082 | espe_delatorre@hotmail.com | |
| Juan Carlos J Castillo Farfan, Doctor | Contact | +34650562634 | jcastillo@institutobernabeu.com |
| Name | Affiliation | Role |
|---|---|---|
| Juan Carlos J Castillo Farfan, Doctor | Instituto Bernabeu Alicante | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Bernabeu | Recruiting | Madrid | 28001 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 29, 2022 | Jul 17, 2023 | ICF_000.pdf |
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| 5-6 weeks gestational age. |
| Ectopic pregnancy | ultrasonic or surgical visualization of a pregnancy outside of the endometrial cavity. | 5-8 weeks gestational age. |
| Early pregnancy loss | spontaneous pregnancy demise before 10 weeks of gestational age (before 8th developmental week). | 5-10 weeks gestational age. |