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Amenorrhea clinical trials

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NCT ID: NCT06280807 Recruiting - Hypogonadism Clinical Trials

Observation of Environment and Reproductive-Endocrine Effects

Start date: April 26, 2024
Phase:
Study type: Observational

Background: Endocrine disorders occur when the glands that make hormones do not work properly. Hormones levels that are too high or too low can cause problems such as late or early puberty, irregular periods, and infertility. Environmental factors - including pollution; chemical exposure at home and work; foods; medicines; and sleep habits - may cause problems with the endocrine and reproductive systems. Objective: To learn how environmental factors may affect the endocrine and reproductive systems. Eligibility: Males or females, referring to sex assigned at birth, aged 8 years and older; they must have hypogonadism, infertility, or other reproductive disorders. Design: Adult participants will have 4 to 5 visits in 5 years. Children may have up to 12 visits; they may remain in the study up to the age of 23. Most visits will be less than 3 hours. Participants will be screened. They will have a physical exam. They will have blood and urine tests. They will complete questionnaires; they will answer questions about their diet, health, and other topics. Some may be referred for additional tests, such as imaging scans and semen analysis. Specific tests conducted during study visits will vary, depending on the participant s diagnosis. In addition to repeated blood and urine tests, these may include: Body composition measure: Participants will sit in a pod-shaped machine for about 6 minutes. The machines measures the air inside the capsule to record body fat and breathing volume. Resting energy expenditure test: Participants will lie down with a clear dome placed over their head. They will breathe quietly for 30 minutes. This test measures the number of calories their body burns at rest. ...

NCT ID: NCT06078618 Completed - Clinical trials for Premature Between 32 and 36 Weeks of Amenorrhoea

Place of Birth and Neonatal Health in Cases of Premature Birth Between 32 and 36 Weeks of Amenorrhoea

PREM3236
Start date: January 1, 2022
Phase:
Study type: Observational

Moderate and late premature babies (32-36 weeks of amenorrhoea) account for around 6% of births, but 20% of neonatal deaths. These children also have an increased risk of neonatal morbidity and long-term neurodevelopmental sequelae compared with full-term newborns. In the case of preterm birth, optimal antenatal, birth and postnatal management is necessary to prevent neonatal complications and mitigate longer-term consequences. However, we lack knowledge about the management of this at-risk population and the factors influencing their health. This knowledge is needed in the current context of unfavourable trends in neonatal health. Over the last ten years, neonatal and infant mortality has stagnated in France, with France falling behind other European countries. According to the latest European report, France ranks 22nd out of 33 countries. The causes of this stagnation are not well known, but many hypotheses have been put forward, including sub-optimal organisation of care.

NCT ID: NCT05967819 Recruiting - Clinical trials for Amenorrhea Secondary

Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women

FHA
Start date: August 9, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to determine how changes in exercise and psychosocial stress may influence the risk of menstrual cycle irregularities in female runners and cyclists. The main questions it aims to answer are: - Does the implementation of exercise or psychosocial stress effect circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length? - Is there an additive effect of combined exercise and psychosocial on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length? Participants will be asked to do the following over the ~3 month enrollment period: - attend a laboratory visit at the beginning and end of the study to have their resting metabolic rate, aerobic fitness, and body composition tested - monitor their menstrual cycle length, daily perceived stress levels, physical activity, and diet each month - provide several urine and saliva samples each month - either maintain their usual physical activity and lifestyle habits (control group), increase the duration of their weekly running or cycling mileage by 30% (exercise stress group), complete cognitive function tasks designed to be stressful (psychosocial stress group), or increase the duration of their weekly running or cycling mileage by 30% and complete cognitive function tasks designed to be stressful (exercise + psychosocial stress group) during the final month of enrollment. Researchers will compare control, exercise stress, psychosocial stress, and exercise + psychosocial stress groups to see if there is an effect on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length.

NCT ID: NCT05921877 Recruiting - Clinical trials for Amenorrhea Secondary

AMH and Functional Hypothalamic Amenorrhea

AMELIA
Start date: June 16, 2023
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to analyze AMH levels in patients with prolonged FHA (more than 2 years). Based on previous studies, we can assume that prolonged FHA may mimic a condition of primary hypogonadotropic hypogonadism, due to a lasting interruption of gonadotropin release. Furthermore, after the resumption of the spontaneous menstrual cycle, we will reanalyze AMH levels, which we hypothesize to find higher. If our hypotheses are confirmed correct, we could support the thesis that AMH is not a good index of ovarian reserve in patients with functional hypothalamic amenorrhea.

NCT ID: NCT05737095 Recruiting - Preterm Birth Clinical Trials

Study of the Feasibility of Early Lung Ultrasound in Neonatal Respiratory Distress in Premature Newborns Born Between 32 Weeks of Amenorrhea and 36 Weeks Plus 6 Days of Amenorrhea, Hospitalized in the Neonatal Pediatrics and Intensive Care Units of the Dijon University Hospital

REchoPP
Start date: November 27, 2022
Phase:
Study type: Observational

Monocentric study carried out in the Neonatal and Intensive Care Units of the Dijon University Hospital. The objective is to evaluate the feasibility of performing a pulmonary ultrasound within 6 hours after admission in premature infants born between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days who are hospitalized for initial respiratory distress. Pulmonary ultrasound is performed within 6 hours of admission and an ultrasound score is calculated according to the images observed. Continued management according to protocols without taking into account the ultrasound data. Follow-up of patients until discharge from hospital or D28 of life (whichever comes first)

NCT ID: NCT05633966 Recruiting - Clinical trials for Hypogonadotropic Hypogonadism

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

KASPR
Start date: December 16, 2022
Phase: Phase 1
Study type: Interventional

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.

NCT ID: NCT05629377 Recruiting - Clinical trials for Hypothalamic Amenorrhea

Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH)

ARCH
Start date: January 17, 2023
Phase:
Study type: Observational

Hypothalamic amenorrhea (HA) occurs during reproductive years and results in stopped menstrual cycles and infertility which can be prolonged from months to years and is characterized by varying combinations of psychosocial stress, anxiety, high levels of physical activity, and/or weight loss. Data from our group indicates that one-third of women with HA (mean age: 27 yrs) have preclinical cardiovascular disease (CVD) measured noninvasively as vascular dysfunction and vascular inflammation. This study will use HA as a marker of fertility status for cardiovascular health and perform dense-phenotyping using remote patient monitoring (FitBit) and patient reported outcomes (questionnaires) to determine which HA phenotypes are related to preclinical CVD and inflammation.

NCT ID: NCT05544097 Recruiting - Clinical trials for Necrotizing Enterocolitis

Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis

BHAPE
Start date: September 6, 2022
Phase: N/A
Study type: Interventional

The recording or bowels is easy and cheap. The investigators wonder if these sounds are modified in babies with high risk of necrotizing enterocolitis. In this study, the investigators suggest to record and do a spectral analysis of 30 seconds of bowel sounds in preterm babies of less than 32WA before and after enteral nutrition, every day until the end of hospitalization. A spectral analysis will be made for each record to determine frequencies of the signal. The investigators will try to determine physiological frequencies and look for modifications in pathological situations.

NCT ID: NCT05410886 Recruiting - Clinical trials for Amenorrhea Secondary

Screening Women for Functional Hypothalamic Amenorrhea (FHA)

Start date: June 1, 2022
Phase:
Study type: Observational

What do the investigators know already? Many women suffer loss of periods (amenorrhoea). One of the most common causes of period loss is called 'functional hypothalamic amenorrhea' (FHA). FHA is difficult to diagnose and may be mistaken for other conditions causing period loss, such as polycystic ovarian syndrome (PCOS). This could cause delays in starting the correct treatment. What is the justification for doing this study? Undiagnosed women with FHA are predisposed to complications related to low oestrogen levels, such as osteoporosis, bone fractures and infertility. The failure to accurately identify women with FHA and mislabel those women with FHA as having PCOS, may delay appropriate treatment. Treatment delay causes harm for affected women, including bone fractures and infertility. What do the investigators propose? Improve the diagnosis of women with FHA by composing an assessment score, which could be used by women to improve the accuracy of diagnosing FHA. The investigators designed a questionnaire based on literature search, which can be used to identify women with FHA. A questionnaire-based study (on-line or in person) will be performed to identify risk of FHA, in women referred to hospital with period loss.

NCT ID: NCT05177913 Recruiting - Premature Birth Clinical Trials

Assessment of Factors Influencing Parents' Attendance Time During Feeding Time of Premature Infants Born Before 35 Weeks of Amenorrhea in Besançon University Hospital

PréPaLim
Start date: September 16, 2021
Phase:
Study type: Observational

The precise description of parental presence and the associated factors will make it possible to construct an intervention in order to correct potentially low parental participation. The demonstration of the effectiveness of such an intervention will be the subject of a larger study (PHRIP type). Ultimately, the investigators want to personalize the daily support for parents to offer optimal support for parenting.