Endometrial Disorder, Infertility, Female, IVF, Pregnancy Early
Conditions
Keywords
infertilty, progesterone, endometrium, pregnancy
Brief summary
For a pregnancy to occur, an euploid embryo at blastocyst developmental stage, a receptive endometrium and the synchrony of both is crucial. Many studies lately investigated the influence of the endometrial thickness and pattern on the artificial reproductive technology (ART) outcome, however, with conflicting results.
Detailed description
Further on, the measurement of the endometrial thickness was mostly performed either on the day of final oocyte maturation in stimulated cycles with fresh embryo transfer or on the day of progesterone administration in FET cycles. Progesterone is essential for the secretory transformation and compaction of the endometrium, prior to implantation. A recently published paper (Haas et al., 2019) however, evaluated the degree of endometrial compaction under the influence of progesterone in FET cycles and described, that a lack of certain endometrial compaction has a negative impact on the ongoing pregnancy rate. As in this study embryos of unknown ploidy status were transferred, the role of embryo ploidy on the outcome may bias the study results. In the herein presented study protocol we aim to investigate the influence of endometrial compaction in FET cycles in which euploid embryos are transferred. HYPOTHESIS: Lack of endometrial compaction after the start of progesterone leads to an impaired reproductive outcome.
Interventions
DIAGNOSTIC_TESTBlood test
Mesurement of E2, P4, LH, FSH hormones
DIAGNOSTIC_TESTUltrasound
Follicular measurement and endometrium measurement
Sponsors
ART Fertility Clinics LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Inclusion criteria
* Women aged 18 years to 40 years with regular menses (26-34 days) * Having 1 or 2 chromosomally normal cryopreserved blastocysts available for transfer after IVF / ICSI treatment * First frozen-thawed transfer cycle * Progesterone level \< 1.5 ng/mL day of trigger injection in stimulation cycle from which embryos to be transferred were created.
Exclusion criteria
* Polycystic ovarian syndrome * Poor ovarian responder in accordance with Bologna criteria * Uterine abnormality US / saline infusion sonohysterogram * Previous dilatation & curettage (D&C) * Hydrosalpinx * Asherman syndrome * History of endometriosis AFS ≥ 2 * ICSI due to severe male factor with testicular sperm * Any known contraindications or allergy to oral estradiol or progesterone. * Discontinuation of HRT medication ( medication error in research HRT cycle ) * Failure to detect ovulation in the research natural cycle * Ovulation after day 20 in a natural cycle * Duration of estradiol exposure ≥ 17 days and endometrium \< 6mm * Spontaneous ovulation in HRT artificial cycle
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 12 weeks | Ongoing pregnancy rate (≥ 12 weeks) in patients with endometrial compaction compared to patients without endometrial compaction after frozen embryo transfer of 1 or 2 euploid blastocysts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical pregnancy rate in HRT cycle | 5 weeks | Positive hCG, but at 5 gestational weeks no ultrasonographic visible gestational sac seen after embryo transfer in HRT-FET cycles with one or two euploid embryos, depending on the degree of compaction. |
| Biochemical pregnancy rate in spontaneous cycle | 5 weeks | positive hCG, but at 5 gestational weeks no ultrasonographic visible gestational sac seen) after embryo transfer in NC-FET cycles with one or two euploid embryos, depending on the degree of compaction. |
| Clinical implantation rate in HRT cycle | 6 weeks | Number of gestational sacs observed by ultrasound at 6 weeks of gestation divided by the number of embryos transferred), defined by a ß-hCG of \> 5 IU on day 12 after embryo transfer in HRT-FET cycles with one or two euploid embryos, depending on the degree of compaction |
| Clinical implantation rate in spontaneous cycle | 6 weeks | Number of gestational sacs observed by ultrasound at 6 weeks of gestation divided by the number of embryos transferred), defined by a ß-hCG of \> 5 IU on day 12 after embryo transfer in NC-FET cycles with one or two euploid embryos, depending on the degree of compaction. |
Countries
United Arab Emirates
Outcome results
None listed