Iodine Supplementation and Fertility Parameters
ConditionInfertility (IVF Patients)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorTehran University of Medical Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women with diminished ovarian reserve
Willingness to participate
Age range: 18 to 45 years
Women with a menstrual cycle of 21 to 42 days
Disqualifiers
Unwillingness to participate
Women with polycystic ovary syndrome or endometriosis
Diagnosis of any thyroid disease
Use of any medication that affects the thyroid function
Trial design
Design model
Parallel
Treatments tested in this trial
Iodine
Dietary supplementIn 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
Dietary supplementWomen 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.
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Iodine supplementExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
2 weeks after the start of ovarian stimulation (approximately 2 months after intervention)2
Number of mature (MII) oocytes
Total count of oocytes that have reached the metaphase II stage of meiosis. This measurement is done by embryologists
Time frame
2 weeks after the start of ovarian stimulation (approximately 2 months after intervention)Secondary outcomes
1
Number of embryos
Number of fertilized eggs (oocytes) that develop into embryos after the fertilization process with sperm
Time frame
16-18 hours after insemination2
Quality of embryos
Quality of embryos is graded by embryologists using 3-point score scale
Time frame
3 days after fertilization3
Biochemical pregnancy
Biochemical pregnancy is confirmed by βHCG test
Time frame
12 days after embryo transfer4
Clinical pregnancy
Presence of one or more gestational sacs during transvaginal scans
Time frame
3 weeks after embryo transferLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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