Infertility Due to Nonimplantation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERObservational non intervention study
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.
Sponsors
Universidad Miguel Hernandez de Elche
Instituto Bernabeu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 8-10 weeks gestational age. | Presence of an intrauterine pregnancy with positive embryo heartbeat as seen by sonography at 8-10 weeks gestational age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical pregnancy loss | 9-10 days after the embryo transfer. | Spontaneous pregnancy demise based on decreasing serum b-hCG levels, without an ultrasound evaluation. |
| Clinical pregnancy | 5-6 weeks gestational age. | A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. |
| Ectopic pregnancy | 5-8 weeks gestational age. | ultrasonic or surgical visualization of a pregnancy outside of the endometrial cavity. |
| Early pregnancy loss | 5-10 weeks gestational age. | spontaneous pregnancy demise before 10 weeks of gestational age (before 8th developmental week). |
Countries
Spain
Contacts
Primary ContactEsperanza E de la Torre Pérez, Gynecologist
Backup ContactJuan Carlos J Castillo Farfan, Doctor
Outcome results
None listed