Correlation Between Serum Progesterone Level And Primary Dysmenorrhea

Correlation Between Serum Progesterone Level And Menstrual Symptoms In Young Females With Primary Dysmenorrhea

This study will be conducted to determine Correlation between the levels of serum progesterone and Menstrual Symptoms In Young Females

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Dysmenorrhea

Detailed Description

One hundred adult females with primary dysmenorrhea will participate in this study. They will be recruited from outpatient clinic of Gynaecological outpatient clinic, faculty of physical therapy, Cairo university, Egypt Many studies reported that primary dysmenorrhea was the result of increased prostaglandin, especially prostaglandin F2α (PGF2α) and prostaglandin E2 (PGE2) which produced the effect through the cyclooxygenase pathway, and further led to uterine ischemia hypoxia. Nevertheless the relationship between the serum progesterone level and menstrual symptoms was not completely clear. Hence, this study will investigate the association between the serum progesterone level and menstrual symptoms in young female complain of dysmenorrhea and non-dysmenorrhea.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: MENNAALLAH YOUSEF NASRELDIEN, PhD; Phone Number: 01142896492; Email: mennatullahyousef@pt.suez.edu.eg
• Study Contact Backup: Name: MANAL ELSHAFEI, PhD; Phone Number: PhD 01220664518; Email: Manal.Ahmed@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

One hundred girls with dysmenorrhoea. Menarche at least 3 years ago. All females should be regular cycle with evidence of ovulation.

Description

Inclusion Criteria:

1. One hundreds adult females were suffered from primary dysmenorrhea.
2. Their age was ranged from 17 to 24 years.
3. Their body mass index was ranged from 20 to 25 kg/m2.

Exclusion Criteria:

• Any participant will be excluded from the study if they have:

  1. Irregulars or infrequent menstrual cycles.
  2. Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis.
  3. Pelvic pathology.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

One group quasi-experimental study; One hundred adult females with primary dysmenorrhea and non-dysmenorrhea will participate in this study. They will be recruited from outpatient clinic of Gynaecological outpatient clinic, faculty of physical therapy, Cairo university, Egypt. All females should be regular cycle with evidence of ovulation.Taking blood samples of 3 ml through the cubit vein to examine the levels of serum progesterone Will be carried out on the 21st day of menstruation, while to assess the pain intensity of primary dysmenorrhea using the Visual Analogue Scale (VAS) and physical and psychological symptoms associated with dysmenorrhoea will be assessed by menstrual symptoms questionnaire .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum progesterone level	Blood samples will be taken by physician for each girl, and will send to laboratory center to measure the progesterone level in the blood. The normal serum progesterone level at 21st day is 4-20ng	Up to 3 months
Pain intensity	It will be measured by Visual analogue scale. It is a graphic rating scale with numerical values placed equidistantly along the line. The descriptors and numbers help the subject to place her estimate on line in which 0 mean no pain,1 equal mild pain, 2 equal moderate pain, 3 mean sever pain and 4 mean unbearable pain.	Up to 3 months
Physical and psychological symptoms	It will be measured by menstrual symptoms questionnaire. It was 13 item of 22 item of c-form MSQ (CMSQ) which used to assess the physical and psychological symptoms associated with dysmenorrhea.The score on each item ranged from 1 (never) to 5 (always) with a higher composite score indicating more symptoms	Up to 3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: HANAA HAFEZ, PhD, Lecturer of Physical Therapy for Orthopedic. Physical Therapy, Nahda University.; Study Director: RANIA Hamed, PhD, Lecturer of Physical Therapy for Basic Science. Physical Therapy, Nahda University.; Study Director: ESRAA MOHAMED, PhD, Lecturer Of Physical Therapy For Cardiovascular, Respiratory and Geriatrics.; Study Director: HOSSAM HUSSIEN, PhD, Faculty of Medicine, Al-Azhar University.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 30, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Visual analogue scale; Dysmenorrhoea; Serum progesterone level; Menstrual symptoms questionnaire
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: P.T.REC/012/005016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No