Clinical trial · Interventional
Vitamin D Supplementation and Improvement of PCOS Therapy and IVF Outcomes in Infertile Saudi Women
Effects of Vitamin D Supplementation on Reproductive, Hormonal and Metabolic Profiles, and on IVF Outcomes, in PCOS Infertile Saudi Women : a Randomized-controlled Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized double-blinded-controlled clinical trial consists of two protocols as follow: protocol 1: evaluation of the therapeutic effects of Vitamin D3 supplement when given alone and in combination with an ovulation-inducing agent (e.g., Clomiphene citrate or Letrozole) on ovarian functional status and hormonal and metabolic features of PCOS-Vitamin D-deficient infertile Saudi women; and protocol 2: evaluation of the effectiveness of Vitamin D3 supplement versus placebo on the clinical pregnancy rate, fertilization implantation rate, live birth rate, and other outcome parameters following in-vitro fertilization (IVF) application in these PCOS-Vitamin D-deficient infertile patients.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Female Infertility | — | UNRESOLVED | — |
| IVF | — | UNRESOLVED | — |
| Pathologic Processes | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
| Vitamin D Deficiency | — | UNRESOLVED | — |
| Vitamin D Supplement | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clomiphene Citrate | Drug | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
| placebo | Other | — | UNRESOLVED |
| Vitamin D3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Vitamin D3
- description
- Participants will be treated with oral vitamin D3 4000IU capsules per day for around 12 weeks
- interventionNames
- Drug: Vitamin D3
- type
- ACTIVE_COMPARATOR
- label
- Ovulation-inducing drug "Clomiphene citrate"
- description
- Participants will be treated with oral Clomiphene citrate using its respective "Stair-step dosage protocol" as follow: 50 mg, 100 mg, and 150 mg, once daily for 5 days, in the 1st, 2nd, and 3rd cycle, respectively.
- interventionNames
- Drug: Clomiphene Citrate
- type
- ACTIVE_COMPARATOR
- label
- Ovulation-inducing drug "Letrozole"
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 42 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged 20 to 42 years old; 2. Diagnosed with PCOS (Rotterdam Criteria); 3. Written informed consent. Exclusion Criteria: 1. Non-PCOS Infertile patients, e.g, who have Cushing's syndrome, congenital adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia. 2. PCOS patients who are underwent any anti-infertility treatments. 3. PCOS patients who had receiving any vitamin D supplement or any multivitamin supplement within the past 3 month prior to enrollment process. 4. PCOS patients with established diagnosis of diabetes mellitus, chronic liver, kidney, or thyroid diseases. 5. PCOS patients receiving any treatment affect the metabolism of vitamin D. 6. Any supplements that contain vitamin D within the past month.
References
Publications (0)
Data not yet available