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 The scarce and outdated available data suggest high percentages of women experiencing perimenstrual symptoms, such as premenstrual syndrome or menstrual pain, as well as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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
-
-
-
Madrid, 스페인
- 모병
- Universidad Rey Juan Carlos
-
연락하다:
- Nuria Romero-Parra, Doctor
- 전화번호: +34 617150826
- 이메일: nuria.romero@urjc.es
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Prevalence of symptoms related to menstrual cycle in naturally menstruating females
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Severity of menstrual cycle-related symptoms using the Daily Record of Severity of Problems (DRSP).
기간: Daily through study completion, an average of 3 months.
|
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.
|
Daily through study completion, an average of 3 months.
|
|
Menstrual cycle-related distress using the Menstrual Distress Questionnaire (MEDI-Q).
기간: once, at enrollment (baseline).
|
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.
|
once, at enrollment (baseline).
|
|
Dysmenorrhea using the Disnenorrhea Symptom Interference Scale (DSI)
기간: Daily during bleeding days through study completion, an average of 3 days per month, 3 months.
|
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.
|
Daily during bleeding days through study completion, an average of 3 days per month, 3 months.
|
|
SAMANTA Bleeding Questionnaire.
기간: once, at enrollment (baseline).
|
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.
|
once, at enrollment (baseline).
|
|
Luteinizing hormone (LH) surge prior ovulation
기간: Once a day, during three to five days prior the estimated ovulation day (around mid-cycle) according to participant's cycle retrospective count.
|
Urinary LH test to detect the LH hormone surge occurring 12-36 h prior ovulation.
|
Once a day, during three to five days prior the estimated ovulation day (around mid-cycle) according to participant's cycle retrospective count.
|
|
Ovulation
기간: measured once, in days 6 to 9 after a positive urinary luteinizing hormone (LH) test during each monitored menstrual cycle.
|
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).
|
measured once, in days 6 to 9 after a positive urinary luteinizing hormone (LH) test during each monitored menstrual cycle.
|
|
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Value
기간: once, at enrollment (baseline).
|
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.
|
once, at enrollment (baseline).
|
|
Health-related quality of life assessed using the EuroQol Visual Analogue Scale (EQ-VAS)
기간: once, at enrollment (baseline).
|
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.
|
once, at enrollment (baseline).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serum estradiol concentrations
기간: 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)
|
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).
|
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)
|
|
Serum progesterone concentrations
기간: 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)
|
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).
|
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)
|
|
Serum gonadotropin concentrations: luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
기간: 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)
|
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.
|
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)
|
|
Serum testosterone concentrations
기간: 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)
|
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).
|
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)
|
|
Lipid profile biomarkers assessed from venous blood samples
기간: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
|
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.
|
Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
|
|
Fasting glucose concentrations
기간: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
|
Fasting glucose concentrations to assess glycemic health status will be assessed.
Unit of measure: mg/dL.
|
Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
|
|
Fasting insulin concentrations
기간: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
|
Fasting insulin concentrations to assess glycemic health status will be assessed.
Unit of measure: µIU/mL.
|
Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
|
|
Glycated hemoglobin (HbA1c) concentrations.
기간: Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
|
Glycated hemoglobin (HbA1c) concentrations from venus samples to assess average glycemic status will be obtained.
Unit of measure: %
|
Once, at the mid-luteal phase of the cycle (cycle days 21-25 aproximately).
|
|
Serum high-sensitivity C-reactive protein (hs-CRP) concentrations
기간: Once, at the mid-luteal phase of the cycle (cycle days 21-25, aproximately).
|
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.
|
Once, at the mid-luteal phase of the cycle (cycle days 21-25, aproximately).
|
|
Serum homocysteine concentrations
기간: Once, at the mid-luteal phase of the cycle (days 21-25 aproximately).
|
Serum homocysteine will be assessed from venous blood samples as a biomarker associated with systemic inflammation and cardiometabolic health.
Unit of measure: µmol/L.
|
Once, at the mid-luteal phase of the cycle (days 21-25 aproximately).
|
|
Bone mineral density assessed using dual-energy X-ray absorptiometry (DXA)
기간: Baseline
|
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.
|
Baseline
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 41-01-ID25
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .