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Extensive monitoring of the natural menstrual cycle using the serum biomarkers estradiol, luteinizing hormone and progesterone.

ABSTRACT: Expected values for estradiol (E2), luteinizing hormone (LH), and progesterone determined in serum allow accurate assessment of menstrual cycle phase. Automated immunoassays demonstrate variable degrees of bias, emphasizing the need to establish method-specific reference values. We therefore established method-specific reference intervals for the Elecsys® LH assay and new generation Elecsys Estradiol III and Progesterone III assays (cobas e 801 analyzer) in 85 apparently healthy women aged 22-37 (US)/18-37 (EU) years over one natural menstrual cycle. Cycle length and day of ovulation were standardized; phases were defined by LH surge and/or progesterone/E2 levels. Median (5th-95th percentile) concentrations (follicular/ovulation/luteal) were E2: 198 pmol/L (114-332), 757 pmol/L (222-1959) and 412 pmol/L (222-854); LH: 7.14 IU/L (4.78-13.2), 22.6 IU/L (8.11-72.7) and 6.24 IU/L (2.73-13.1); progesterone: 0.212 nmol/L (0.159-0.616), 1.81 nmol/L (0.175-13.2) and 28.8 nmol/L (13.1-46.3). Sub-phase (early/intermediate/late) reference values were also determined for follicular and luteal phases. This multicenter study established reliable, method-specific E2, LH and progesterone reference values that could assist clinical decision-making in women with fertility disorders and monitoring of natural cycles in assisted reproductive treatment.

SUBMITTER: Anckaert E

PROVIDER: S-EPMC8042396 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Introduction Frozen embryo transfer is being increasingly used for assisted reproductive therapy and offers similar pregnancy rates as treatment with fresh embryo transfer. In women with regular menstrual cycles, transfer of a frozen thawed blastocyst can be performed in either natural cycle or substituted cycle. Anovulatory women can only be offered a substituted or a stimulated cycle. Knowledge on fetal exposure to estradiol in early pregnancy is very limited, but studies on mice and rats have shown hormonal and metabolic disturbances in cubs born from estradiol-exposed mothers. We aim to investigate serum estradiol and progesterone levels in women who conceived after natural, estradiol and progesterone, or gonadotrophin stimulated frozen embryo transfer. Methods and analysis The study is an open-label, randomised controlled trial with normo-ovulatory women being randomised to natural cycle or estradiol and progesterone substitution and anovulatory women being randomised to estradiol and progesterone substitution or gonadotrophin stimulation. Serum estradiol and progesterone will be measured every 2 weeks from cycle days 2–3 until gestational age 9+6. Serum levels will be compared according to treatment regimens and cycle length. Furthermore, obstetric outcomes (live birth rates, birth weight, gestational age at birth, complications and malformations) and a possible association with serum estradiol and progesterone levels will be evaluated. Ethics and dissemination The three treatment regimens are all standard treatments and are comparable with regard to pregnancy rates. Patients will be following routine treatments and thus discomforts are limited to routine transvaginal ultrasound scans and additional blood testing. The study is approved by the Scientific Ethical Committee of the Capital Region of Denmark and the Danish Medicines Agency. The study will be carried out in accordance with the Declaration of Helsinki and monitored by a good clinical practice unit. Positive, negative and inconclusive findings will be published in international peer-reviewed journals. Trial registration number NCT04997525, 2020-001218-39.

Project description:Background and Objectives: The Quantum Menstrual Health Monitoring Study will measure four key reproductive hormones in the urine (follicle-stimulating hormone, FSH; estrone-3-glucuronide, E13G; luteinizing hormone, LH; and pregnanediol glucuronide, PDG) to characterize patterns that predict and confirm ovulation, referenced to serum hormones and the gold standard of the ultrasound day of ovulation in participants with regular cycles. These normal cycles will provide a reference for comparison to irregular cycles in subjects with polycystic ovarian syndrome (PCOS) and athletes. Materials and Methods: Participants will track their menstrual cycles for 3 months and be provided with an at-home urine hormone monitor (Mira monitor) to predict ovulation. The day of ovulation will be confirmed with serial ultrasounds completed in a community clinic. Urine results will be compared to serum hormone values. Other markers of menstrual health, such as bleeding patterns and temperature changes, will be determined using a customized app. Three groups will be recruited. Group 1 will include those with consistent regular cycle lengths (between 24-38 days), and will be compared to two groups with irregular cycle lengths (with increased cycle length variability and longer cycles). Group 2 will include those with polycystic ovarian syndrome (PCOS) with irregular cycles and Group 3 will include individuals participating in high levels of exercise with irregular cycles. Hypothesis: The Mira monitor quantitative urine hormone pattern will accurately correlate with serum hormonal levels and will predict (with LH) and confirm (with PDG) the ultrasound day of ovulation in those with regular cycles as well as those with irregular cycles. Rationale: Once the ultrasound validation is complete, tools like the Mira monitor with a customized app may become a new standard for at-home and remote clinical monitoring of the menstrual cycle without having to use labor-intensive follicular-tracking ultrasound or follow serum hormone changes. Conclusions: Precision monitoring of the menstrual cycle is expected to impact individuals who want to increase their menstrual health literacy and guide decisions about fertility.

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Extensive monitoring of the natural menstrual cycle using the serum biomarkers estradiol, luteinizing hormone and progesterone.

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