Vitamin D Supplementation and Improvement of PCOS Therapy and IVF Outcomes in Infertile Saudi Women

NCT05106712 | Unknown

• 1 other identifier: (AMSEC 82/1-4-2021)
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Female Infertility; Polycystic Ovary Syndrome; Pathologic Processes; Vitamin D Deficiency; IVF; Vitamin D Supplement

Keywords

Polycystic Ovary Syndrome; IVF; Vitamin D; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Clinical pregnancy

  Clinical pregnancy is defined as at least one gestational sac on ultrasound at around 7 weeks' gestation with the detection of heart beat activity after the completion of the first embryo transfer

  through study completion, an average of 18 months

• Number of Participants with live birth

  Live birth is defined as the delivery of at least one baby after 24 weeks of gestation that exhibits any sign of life

  through study completion, an average of 18 months

Secondary Outcomes (2)

• Number of participants with Pregnancy loss rate

  through study completion, an average of 18 months

• Number of participants with improved metabolic parameters

  through study completion, an average of 18 months

Study Arms (4)

Vitamin D3

EXPERIMENTAL

Participants will be treated with oral vitamin D3 4000IU capsules per day for around 12 weeks

Drug: Vitamin D3

Ovulation-inducing drug "Clomiphene citrate"

ACTIVE COMPARATOR

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.

Drug: Clomiphene Citrate

Ovulation-inducing drug "Letrozole"

ACTIVE COMPARATOR

Participants will be treated with oral Letrozole using its respective "Stair-step dosage protocol" as follow: 5 mg, 5 mg, and 7.5 mg, once daily for 5 days, in the 1st, 2nd, and 3rd cycle, respectively, respectively.

Drug: Letrozole

Placebo

PLACEBO COMPARATOR

PCOS-Vitamin D-deficient infertile women in the control (Placebo) group will be treated with equal amount of placebo tablets per day for the same duration.

Other: placebo

Interventions

Vitamin D3 DRUG

4000IU per day for around 12 weeks.

Vitamin D3

Clomiphene Citrate DRUG

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.

Ovulation-inducing drug "Clomiphene citrate"

Letrozole DRUG

oral Letrozole using its respective "Stair-step dosage protocol" as follow: 5 mg, 5 mg, and 7.5 mg, once daily for 5 days, in the 1st, 2nd, and 3rd cycle, respectively, respectively.

Ovulation-inducing drug "Letrozole"

placebo OTHER

participants in the control (Placebo) group will be treated with equal amount of placebo tablets per day for the same duration

Placebo

Eligibility Criteria

• Age: 20 Years - 42 Years
• Gender Eligibility Details: Infertile Saudi women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 20 to 42 years old;
• Diagnosed with PCOS (Rotterdam Criteria);
• Written informed consent.

You may not qualify if:

• Non-PCOS Infertile patients, e.g, who have Cushing's syndrome, congenital adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia.
• PCOS patients who are underwent any anti-infertility treatments.
• PCOS patients who had receiving any vitamin D supplement or any multivitamin supplement within the past 3 month prior to enrollment process.
• PCOS patients with established diagnosis of diabetes mellitus, chronic liver, kidney, or thyroid diseases.
• PCOS patients receiving any treatment affect the metabolism of vitamin D.
• Any supplements that contain vitamin D within the past month.

Sponsors & Collaborators

• Umm Al-Qura University: lead

MeSH Terms

Conditions

Infertility, Female; Polycystic Ovary Syndrome; Pathologic Processes; Vitamin D Deficiency

Interventions

Cholecalciferol; Clomiphene; Letrozole

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and most researchers will be unaware of the actual grouping. Only two investigators who will be not involved in participant management or data analysis will be aware of the grouping. Vitamin D3, Clomiphene citrate, Letrozole and placebo pills with identical package, size, color and appearance will be used in this trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Assisted Reproduction Technology

Model Details: the present intervention trial is designed to achieve the following two objectives: 1) measurement of the therapeutic effects of Vitamin D3 supplement alone and in combination with an ovulation-inducing agent (e.g., Clomiphene citrate or Letrozole) on the ovarian functional status and the hormonal and metabolic features of PCOS-Vitamin D-deficient infertile Saudi women; and 2) measurement 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 PCOS-Vitamin D-deficient infertile patients.

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 4, 2021
• Study Start: November 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 4, 2021

Record last verified: 2021-10