Impact of Endometrial Compaction on Reproductive Outcomes After Cryotransfer of Euploid Embryos in a Natural Cycle

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorInstituto Bernabeu

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 to 50 years

Primary or secondary infertility

Normal uterine cavity

Endometrial preparation in a modified natural cycle for single embryo transfer

Disqualifiers

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).

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational non intervention study

    Other intervention

    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.

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: exposed or "compaction" group1 intervention
Group B: non-exposed "non-compaction" group1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

Ectopic pregnancy

ultrasonic or surgical visualization of a pregnancy outside of the endometrial cavity.

Time frame
5-8 weeks gestational age.
4

Early pregnancy loss

spontaneous pregnancy demise before 10 weeks of gestational age (before 8th developmental week).

Time frame
5-10 weeks gestational age.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto Bernabeu

Lead sponsor

Universidad Miguel Hernandez de Elche

Collaborator