An observational study in Infertility Due to Nonimplantation, sponsored by Instituto Bernabeu. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Instituto Bernabeu · Observational
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 206 is close to the median of 200 across 714 observational studies indexed under Infertility.
Browse Infertility studies →Instituto Bernabeu is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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).
Other: Observational non intervention study
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).
Other: Observational 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.
Ongoing pregnancy rate
Presence of an intrauterine pregnancy with positive embryo heartbeat as seen by sonography at 8-10 weeks gestational age.
Time frame: 8-10 weeks gestational age.
Biochemical pregnancy loss
Spontaneous pregnancy demise based on decreasing serum b-hCG levels, without an ultrasound evaluation.
Time frame: 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.
Time frame: 5-6 weeks gestational age.
Ectopic pregnancy
ultrasonic or surgical visualization of a pregnancy outside of the endometrial cavity.
Time frame: 5-8 weeks gestational age.
Early pregnancy loss
spontaneous pregnancy demise before 10 weeks of gestational age (before 8th developmental week).
Time frame: 5-10 weeks gestational age.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Instituto Bernabeu