Iodine Supplementation and Fertility Parameters

The Effect of Iodine Supplementation on Fertility Parameters in Women Experiencing Infertility

Iodine has been identified as a potential factor influencing female fertility during the childbearing years. The American Thyroid Association recommends that women attempting to conceive take a supplement containing 150 µg of iodine. However, no clinical trials have specifically examined the necessity of iodine supplementation in women experiencing infertility. Furthermore, no information is available on the optimal dose and duration of iodine supplementation to increase the chances of successful treatment in this group of women. Therefore, this study aims to investigate the effects of iodine supplementation on fertility parameters in infertile women.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility (IVF Patients)
• Intervention / Treatment: Dietary supplement: Iodine; Dietary supplement: Placebo

Detailed Description

This double-blind randomized clinical trial will be conducted in infertility clinic on women with diminished ovarian reserve and undergoing in vitro fertilization (IVF) cycle treatment. According to the Bologna criteria, decreased ovarian reserve is defined as having 3 to 5 antral follicles and an anti-Müllerian hormone concentration ranging from 0.1 to 1.5 ng/ml. All women diagnosed with diminished ovarian reserve who meet the inclusion and exclusion criteria outlined in the general information section of the clinical trial and have provided written consent to participate will be examined. Following enrollment and baseline measurements, women will be randomly assigned to treatment groups-placebo and iodine supplement (150 µg/day of iodine)-in a 1:1 allocation ratio, using a random number table. In the intervention group, women will take 150 µg of iodine daily (one tablet per day, Tavan Institute, Tehran, Iran) for two months prior to starting the new IVF cycle. In the control group, participants will take a placebo tablet daily (containing white wheat flour, designed to match the size, shape, and color of the iodine tablet, Tavan Institute, Tehran, Iran) for the same duration before beginning the new IVF cycle. Women of two groups will be followed until the end of IVF cycle. Women in both groups will be monitored until the completion of the IVF cycle. Throughout the study, the following parameters will be assessed based on the timeline of the IVF cycle: the number of retrieved oocytes, the number of mature (MII) oocytes, the number of embryos, embryo quality, biochemical pregnancy, and clinical pregnancy.

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Pantea Nazeri, Associate Professor; Phone Number: +98 21 61192357; Email: nazeri.pantea@gmail.com/pnazeri@tums.ac.ir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women with diminished ovarian reserve
• Willingness to participate
• Age range: 18 to 45 years
• Women with a menstrual cycle of 21 to 42 days
• Women who have not used any contraceptive methods in the past 12 months
• Women who have not had in sexual intercourse for more than 2 months

Exclusion Criteria:

• Unwillingness to participate
• Women with polycystic ovary syndrome or endometriosis
• Diagnosis of any thyroid disease
• Use of any medication that affects the thyroid function
• Use of dietary supplements containing iodine (excluding those considered in the present study)
• Use of iodine-containing disinfectants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iodine supplement; In intervention group women will take 150 µg daily (one tablet per day, Tavan Institute, Tehran, Iran) that will be 2 months before starting the new in vitro fertilization (IVF) cycle.	Dietary supplement: Iodine; In intervention group women will take 150 µg daily (one tablet per day, Tavan Institute, Tehran, Iran) that will be 2 months before starting the new in vitro fertilization (IVF) cycle.
Placebo Comparator: Placebo; Women will take a placebo tablet daily (containing white wheat flour, which is similar to iodine table in terms of size, shape, and color, Tavan Institute, Tehran, Iran) 2 months before starting the new IVF cycle.	Dietary supplement: Placebo; Women will take a placebo tablet daily (containing white wheat flour, which is similar to iodine table in terms of size, shape, and color, Tavan Institute, Tehran, Iran) 2 months before starting the new IVF cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of retrieved oocytes	Total count of mature eggs (oocytes) collected from a woman's ovaries during an IVF cycle through the egg retrieval procedure by embryologists	2 weeks after the start of ovarian stimulation (approximately 2 months after intervention)
Number of mature (MII) oocytes	Total count of oocytes that have reached the metaphase II stage of meiosis. This measurement is done by embryologists	2 weeks after the start of ovarian stimulation (approximately 2 months after intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of embryos	Number of fertilized eggs (oocytes) that develop into embryos after the fertilization process with sperm	16-18 hours after insemination
Quality of embryos	Quality of embryos is graded by embryologists using 3-point score scale	3 days after fertilization
Biochemical pregnancy	Biochemical pregnancy is confirmed by βHCG test	12 days after embryo transfer
Clinical pregnancy	Presence of one or more gestational sacs during transvaginal scans	3 weeks after embryo transfer

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 1402-4-418-69386

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No