Iodine Supplementation and Fertility Parameters

NCT06721273 | Not Yet Recruiting

• 1 other identifier: 1402-4-418-69386
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infertility (IVF Patients)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Number of embryos

  16-18 hours after insemination

• Quality of embryos

  3 days after fertilization

• Biochemical pregnancy

  12 days after embryo transfer

• Clinical pregnancy

  3 weeks after embryo transfer

Study Arms (2)

Iodine supplement

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Iodine DIETARY_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.

Iodine supplement

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

MeSH Terms

Conditions

Infertility

Interventions

Iodine

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Halogens; Elements; Inorganic Chemicals

Central Study Contacts

Dr. Pantea Nazeri, Associate Professor

CONTACT

+98 21 61192357; nazeri.pantea@gmail.com/pnazeri@tums.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 6, 2024

Record last verified: 2024-12