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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05106712
Other study ID # (AMSEC 82/1-4-2021)
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date November 1, 2023

Study information

Verified date October 2021
Source Umm Al-Qura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Drug:
Vitamin D3
4000IU per day for around 12 weeks.
Clomiphene Citrate
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.
Letrozole
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.
Other:
placebo
participants in the control (Placebo) group will be treated with equal amount of placebo tablets per day for the same duration

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Umm Al-Qura University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Number of participants with Pregnancy loss rate Pregnancies that result in a abortion at any point throughout pregnancy through study completion, an average of 18 months
Secondary Number of participants with improved metabolic parameters Pre- and post-intervention plasma levels of glucose, insulin, vitamin D, reproductive adipocytokines, and lipid profile through study completion, an average of 18 months
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