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Tests treatment safety and results for Anovulatory Infertility
Official title Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
ClinicalTrials.gov ID: NCT06045351
What this study is testing
What is Vitamin D?
Vitamin D is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for anovulatory infertility.
Also referred to as Experimental, Group A.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Poly cystic Ovarian Syndrome (PCOS) is an endocrine disorder of reproductive age defined by "the presence of any two out of three criteria: oligo and/or anovulation, excess androgen activity and/or polycystic ovarian morphology on ultrasound". Considering role of vitamin D (VD) (3, 4) and high prevalence (58%) of deficiency in PCOS of Pakistan.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Recently diagnosed PCOS with presence of at least 2 of these 3 elements: clinical or biochemical signs of hyperandrogenism, chronic anovulation and...
You likely can't join if
- : Exclusion of people will be done by the Co-Principal Investigators (Co-PI) after history, examination and complete evaluation in the respective...
- Pregnancy
- Hypercalcemia (plasma calcium concentrations\> 2.65 mmol/L)
- Tuberculosis or other granulomatous disorders
- Chronic liver disease or alanine transaminase (ALT) level 3 times higher than the normal limit, chronic
- Kidney disease or serum creatinine \>2.0 mg/dL,
See the full eligibility criteria
- Recently diagnosed PCOS with presence of at least 2 of these 3 elements: clinical or biochemical signs of hyperandrogenism, chronic anovulation and polycystic ovaries (1) (from reports of available routine TVS), with...
- : Exclusion of people will be done by the Co-Principal Investigators (Co-PI) after history, examination and complete evaluation in the respective clinics. All female people meeting any of the following criteria will be...
- Pregnancy
- Hypercalcemia (plasma calcium concentrations\> 2.65 mmol/L)
- Tuberculosis or other granulomatous disorders
- Chronic liver disease or alanine transaminase (ALT) level 3 times higher than the normal limit, chronic
- Kidney disease or serum creatinine \>2.0 mg/dL,
- Drug Therapies: VD replacement ; participants who had received VD injection in the last 3 months prior to recruitment in the study, oral contraceptives, hormonal replacement therapy, glucocorticoids, calcium...
- Suffering from congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, type 2 Diabetes Mellitus, renal, hepatic or thyroid disorders, hyperparathyroidism, malabsorption syndromes, Chronic Kidney...
The study team makes the final eligibility decision.
Where it's taking place
- Karachi, Sindh, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Karachi, Sindh, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.