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Effects of Wet-Cupping on Polycystic Ovary Syndrome Patients

Sponsored by Princess Nourah Bint Abdulrahman University

About this trial

Last updated 9 months ago

Study ID

250094

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

20 to 40 Years
Female

Trial Timing

Started 5 months ago

What is this trial about?

The goal of this clinical trial is to evaluate whether wet cupping therapy (Hijama) can improve reproductive and metabolic outcomes in women diagnosed with Polycystic Ovary Syndrome (PCOS). This study will be conducted among female participants aged 20-40 years who have been diagnosed with PCOS according to the Rotterdam criteria. The main questions it aims to answer are: Can wet cupping therapy regulate menstrual cycles in women with PCOS? Can it increase the pregnancy rate in married participants with PCOS-related infertility? Researchers will compare outcomes between a wet cupping group and a control group to determine whether Hijama has significant effects on reproductive, hormonal, and metabolic markers. Participants will: Undergo screening and eligibility evaluation using a checklist Be randomized into either the wet cupping (intervention) or control group Receive lifestyle counseling (diet and physical activity) For the intervention group: Receive one Hijama session performed by a certified practitioner Undergo follow-up at 4 and 12 weeks for clinical, hormonal, and ultrasound assessments For all participants: Complete laboratory tests, ultrasound scans, and questionnaires on PCOS symptoms and quality of life Report any side effects during and after the study period

What are the participation requirements?

Inclusion Criteria

* Female participants.

* Aged 20 to 40 years.

* Diagnosed with Polycystic Ovary Syndrome (PCOS) according to the Rotterdam criteria.

* Willing to participate in the study and provide informed consent.

* Not using any of the following in the last month: (Hormonal medications for menstruation, Herbal menstrual remedies or Metformin).

Exclusion Criteria

* Known diagnosis of uncontrolled thyroid dysfunction.

* Diagnosis of diabetes mellitus.

* Elevated FSH levels above 20 mIU/mL.

* Hyperprolactinemia with serum levels above 1000 mIU/L.

* Pregnant or lactating women.

* Known coagulation disorders.

* Anemia with hemoglobin levels less than 10 g/dL.

* History of undergoing dry cupping, wet cupping, or acupuncture in the past 6 months.

* History of surgical removal of both ovaries or the uterus.

* Other causes of hyperandrogenism, including:

* Late-onset non-classic 21-hydroxylase deficiency (excluded clinically; lab investigation if clinically indicated).

* Ovarian androgen-secreting tumors.

* Use of anabolic or androgenic drugs.

* Cushing's syndrome.

* Hypothalamic or pituitary disorders causing amenorrhea.

* Primary ovarian insufficiency.