Correlation Between Serum Progesterone Level And Primary Dysmenorrhea

NCT06359457 | Completed DMC

• 1 other identifier: P.T.REC/012/005016
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to determine the correlation between the levels of serum progesterone and Menstrual Symptoms In Young Females with primary dysmenorrhea.

Conditions

Primary Dysmenorrhea

Keywords

Dysmenorrhoea; Serum progesterone level; Visual analogue scale; Menstrual symptoms questionnaire

Outcome Measures

Primary Outcomes (5)

• 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 4-20 ng

  1 month

• Pain intensity

  It will be measured by Visual analogue scale. It is 10 cm line with values ranging from 0 to 10. 0 indicates no pain nd 10 indicates the worst pain.

  1 month

• Physical and psychological menstrual symptoms

  It will be measured by menstrual symptoms questionnaire. It is 25 items split into two categories 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

  1 month

• Correlation between serum progesterone level and pain

  The correlation between serum progesterone level and pain intensity measured by the VAS will be conducted

  1 month

• Correlation between serum progesterone level and menstrual symptoms

  The correlation between serum progesterone level and menstrual symptoms measured by the menstrual symptom questionnaire will be conducted

  1 month

Study Arms (1)

A group of young females with primary dysmenorrhea

One hundred young females with primary dysmenorrhea will participate in this study. They will be recruited from the Gynecological outpatient clinic, Kasr El Ainy University Hospital, Cairo, Egypt. All females should have regular menstrual cycles. Taking blood samples of 3 ml through the cubital 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 dysmenorrhea will be assessed by menstrual symptoms questionnaire .

Eligibility Criteria

• Age: 17 Years - 25 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

One hundred girls with dysmenorrhoea. Menarche at least 3 years ago. All females should be regular menstrual cycles.

You may qualify if:

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

You may not qualify if:

• Any participant will be excluded from the study if they have:
• Irregulars or infrequent menstrual cycles.
• Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis.
• Pelvic pathology.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Menna Allah Youssef Nasr El-Dien

Cairo, Egypt

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy for women's health

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 11, 2024
• Study Start: May 5, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 31, 2024
• Last Updated: January 29, 2025

Record last verified: 2024-04

Locations

EG (1)