Menstrual Cycle Symptoms and Female Health (CICLOS)
Prevalence of Subclinical Ovulatory Disturbances and Symptoms During the Menstrual Cycle and Their Relationship With Physical and Mental Health in Spanish Women of Reproductive Age (Prevalencia de Alteraciones Ovulatorias subclínicas y síntomas Durante el CICLO Menstrual y su relación Con la Salud física y Mental en Mujeres españolas en Edad Reproductiva).
The complexity inherent to the hormonal fluctuations associated with the female menstrual cycle (MC) has contributed, from a methodological perspective in research, to the neglect of women's physiological characteristics and to the silencing and normalization of symptoms linked to different life stages and hormonal environments. The scarce and outdated available data suggest high percentages of women experiencing perimenstrual symptoms, such as premenstrual syndrome or menstrual pain, as well as intermenstrual discomfort. These symptoms not only significantly impair daily activities but, due to their normalization, often lead to the underdiagnosis of other gynecological conditions.
Subclinical ovulatory disturbances-characterized by the suppression of ovarian hormones as an adaptive defense mechanism against various environmental stressors-are also frequently underdiagnosed. These disturbances typically do not affect MC length, making them difficult to detect, and although the process is reversible, it may initiate irreversible consequences for certain tissues, such as bone mass loss. However, neither women nor their educational, occupational, or healthcare environments appear to have the resources and/or knowledge required to adequately address these issues.
All of this may compromise women's rights to adequate sexual and reproductive health and to a dignified quality of life, as recognized under the second line of Axis 4, "Effective Rights for All Women," of the Strategic Plan for Effective Equality between Women and Men 2022-2025. Therefore, the aims of this multicenter project-carried out by a multidisciplinary research team from seven Spanish universities and three international institutions-are to describe the prevalence of symptoms and alterations related to the MC in women of reproductive age and to identify their associations with physical and mental health.
To accomplish this, an observational study will be conducted in a large sample of women of reproductive age, including multiple symptom and perceived-health questionnaires and ovulation monitoring. In addition, in a subsample of participants, bone mineral density will be assessed, blood levels of sex hormones will be monitored, and an innovative analysis of health biomarkers (glycemic and lipid profile, and inflammation) from menstrual blood will be included. This will be complemented by a qualitative study of experiences related to MC-associated symptoms and alterations, using in-depth interviews and thematic content analysis.
The findings of this project are expected to support various dissemination and educational actions, justify the design of more inclusive educational and healthcare policies, and enhance the understanding of women's needs, ultimately contributing to improved symptom management and quality of life.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Madrid、スペイン
- 募集
- Universidad Rey Juan Carlos
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コンタクト：
- Nuria Romero-Parra, Doctor
- 電話番号：+34 617150826
- メール：nuria.romero@urjc.es
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Females
- Between 18 and 45 years
- Naturally menstruating.
Exclusion Criteria:
- Pregnant or breastfeeding.
- Hormonal contraceptive methods during the 6 months before the study.
- hysterectomy or ooforectomy.
- Smoking.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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Prevalence of symptoms related to menstrual cycle in naturally menstruating females
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Fulfilling the following questionnaires: Daily Record of Severity of Problems (DRSP), Menstrual Distress Questionnaire (MEDI-Q), SAMANTA Bleeding Questionnaire, Dismenorrhea symptom Interference (DSI), EQ-5D-5L questionnaire, quality of life and mental health questionnaires, urine ovulation tests.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Severity of menstrual cycle-related symptoms using the Daily Record of Severity of Problems (DRSP).
時間枠：Daily through study completion, an average of 3 months.
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The DRSP is a prospective and validated questionnaire to assess the presence and severity of premenstrual symptoms.
Participants rate 3 dimensions (depressive, physical and irritability) of symptoms on a 6-point Likert scale ranging from 1 (not at all) to 6 (extreme).
The total symptom score is calculated by summing responses across symptom items, with higher scores indicating greater symptom severity and functional impairment.
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Daily through study completion, an average of 3 months.
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Menstrual cycle-related distress using the Menstrual Distress Questionnaire (MEDI-Q).
時間枠：once, at enrollment (baseline).
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The MEDI-Q is a 25-item instrument designed to assess menstruation-related distress.
It evaluates symptoms including pain, discomfort, emotional and cognitive changes, gastrointestinal symptoms, and alterations in physiological functioning.
The questionnaire provides a Total Score reflecting overall menstrual distress, as well as three subscales: Menstrual Symptoms (MS), Menstrual Symptoms Distress (MSD), and Menstrual Specificity Index (MESI).
Higher scores indicate greater menstrual-related distress.
A Total Score ≥20 has been proposed as indicative of clinically distressful menstruation.
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once, at enrollment (baseline).
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Dysmenorrhea using the Disnenorrhea Symptom Interference Scale (DSI)
時間枠：Daily during bleeding days through study completion, an average of 3 days per month, 3 months.
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The DSI evaluates the extent to which menstrual pain interferes with daily activities, physical functioning, emotional well-being, and social participation on a 6-point Likert scale ranging from 1 (not at all) to 6 (extreme).
The total symptom score is calculated by summing responses across symptom items.
Higher scores indicate greater pain-related interference.
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Daily during bleeding days through study completion, an average of 3 days per month, 3 months.
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SAMANTA Bleeding Questionnaire.
時間枠：once, at enrollment (baseline).
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The SAMANTA Questionnaire is a 6-item screening tool designed to identify heavy menstrual bleeding (HMB) that interferes with quality of life.
Items are answered using a dichotomous yes/no format and generate a total score ranging from 0 to 10 points.
Higher scores indicate greater likelihood of heavy menstrual bleeding affecting daily life.
A total score of 3 or higher suggests clinically relevant heavy menstrual bleeding.
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once, at enrollment (baseline).
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Luteinizing hormone (LH) surge prior ovulation
時間枠：Once a day, during three to five days prior the estimated ovulation day (around mid-cycle) according to participant's cycle retrospective count.
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Urinary LH test to detect the LH hormone surge occurring 12-36 h prior ovulation.
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Once a day, during three to five days prior the estimated ovulation day (around mid-cycle) according to participant's cycle retrospective count.
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Ovulation
時間枠：measured once, in days 6 to 9 after a positive urinary luteinizing hormone (LH) test during each monitored menstrual cycle.
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Ovulation will be confirmed by measurement of mid-luteal serum progesterone concentration.
Ovulation is considered confirmed when progesterone concentrations reach or exceed 16 nmol/L (4.61 ng/mL).
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measured once, in days 6 to 9 after a positive urinary luteinizing hormone (LH) test during each monitored menstrual cycle.
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Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Value
時間枠：once, at enrollment (baseline).
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The EQ-5D-5L Index Value is a standardized measure of health-related quality of life derived from five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Responses are converted into a single index value, with higher values indicating better perceived health status.
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once, at enrollment (baseline).
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Health-related quality of life assessed using the EuroQol Visual Analogue Scale (EQ-VAS)
時間枠：once, at enrollment (baseline).
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The EQ Visual Analogue Scale (EQ-VAS) is a self-rated measure of overall health ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Higher scores indicate better perceived health status.
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once, at enrollment (baseline).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Serum estradiol concentrations
時間枠：At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
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Serum concentrations of estradiol from venous blood samples will be measured to characterize hormonal fluctuations across the menstrual cycle.
Unit of measure: pg/mL (or pmol/L, depending on laboratory equipment).
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At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
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Serum progesterone concentrations
時間枠：At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
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Serum concentrations of progesterone from venous blood samples will be measured to characterize hormonal fluctuations across the menstrual cycle.
Unit of measure: Unit of measure: ng/mL (or nmol/L).
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At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
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Serum gonadotropin concentrations: luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
時間枠：At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
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Serum concentrations of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), will be measured to characterize hormonal fluctuations across the menstrual cycle.
Unit of measure IU/L.
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At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
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Serum testosterone concentrations
時間枠：At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
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Serum concentrations of testosterone from venous blood samples will be measured to characterize hormonal fluctuations across the menstrual cycle.
Unit of measure: Unit of measure: ng/mL (or nmol/L).
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At 4 time points during one menstrual cycle: early follicular phase (cycle days 1-5), late follicular phase (approximately cycle days 10-14), ovulatory phase (12-36 hours after a positive urinary luteinizing hormone test), and mid-luteal phase (6-9 days)
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Lipid profile biomarkers assessed from venous blood samples
時間枠：Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
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Lipid health status will be assessed through measurement of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride concentrations obtained from venous blood samples.
All measurements' units are mg/dL.
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Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
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Fasting glucose concentrations
時間枠：Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
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Fasting glucose concentrations to assess glycemic health status will be assessed.
Unit of measure: mg/dL.
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Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
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Fasting insulin concentrations
時間枠：Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
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Fasting insulin concentrations to assess glycemic health status will be assessed.
Unit of measure: µIU/mL.
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Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
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Glycated hemoglobin (HbA1c) concentrations.
時間枠：Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
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Glycated hemoglobin (HbA1c) concentrations from venus samples to assess average glycemic status will be obtained.
Unit of measure: %
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Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
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Serum high-sensitivity C-reactive protein (hs-CRP) concentrations
時間枠：Once, at the mid-luteal phase of the cycle (cycle days 21-25, aproximately).
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High-sensitivity C-reactive protein (hs-CRP) will be assessed from venous blood samples tas a marker of systemic inflammation.
Unit of measure: mg/L.
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Once, at the mid-luteal phase of the cycle (cycle days 21-25, aproximately).
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Serum homocysteine concentrations
時間枠：Once, at the mid-luteal phase of the cycle (days 21-25 aproximately).
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Serum homocysteine will be assessed from venous blood samples as a biomarker associated with systemic inflammation and cardiometabolic health.
Unit of measure: µmol/L.
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Once, at the mid-luteal phase of the cycle (days 21-25 aproximately).
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Bone mineral density assessed using dual-energy X-ray absorptiometry (DXA)
時間枠：Baseline
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Bone mineral density (BMD) will be assessed using dual-energy X-ray absorptiometry (DXA).
BMD values will be used to evaluate bone health and to explore associations with menstrual cycle characteristics, ovulatory status, and sex hormone concentrations.
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Baseline
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 41-01-ID25
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