An interventional study of Selenium and Sugar Pill Placebo in Pregnancy, Infertility and Auto-immune Thyroiditis, sponsored by University of Roma La Sapienza. Completed at 11 sites in Italy. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2018-01-30.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Prevention
Among 76 studies in Infertility with a site in Italy — 6 open to participants now, 9 under way, none of them phase 3. Infertility · Italy.
Among the 76 studies in Infertility with a site in Italy, this one is the 43rd largest by enrollment of the 53 interventional ones, is one of 11 that started in 2012, is one of 16 with no phase, and was the 24th registered.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 56 is below the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →6 of the 76 studies in Infertility with a site in Italy are open now, in 1 country. Each count lists the studies.
Of the 235 Infertility studies recruiting now, 43 (18%) set no upper age limit and 186 (79%) stop at 75 or younger; 27 take children under 18; 78 take healthy volunteers.
This study: 18 Years to 38 Years · female · no healthy volunteers.
The full table on the hub →76 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 11 started in 2012.
Median enrollment 144 across the 53 interventional studies, 336 across the 22 observational. Of the 48 that completed or were terminated, 8 (17%) have results posted.
13 of 76 have an industry lead sponsor. The 10 most frequent:
University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
University of Roma La Sapienza has 2 studies filed under Infertility — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 76 studies in Infertility with a site in Italy, from their registry updates:
Serum levels of isolated anti-thyroperoxidase (TPOab) and anti-thyreoglobulin (Tgab) autoantibodies are strongly associated with an increased risk of miscarriage and premature deliveries in euthyroid pregnant women. Replacement of thyroxine (LT4) or other supplementations in euthyroid-Ab positivity during pregnancy has not been established. The development of a safe and effective intervention that modulates inappropriate inflammatory responses could be a very important component of prevention against adverse health outcomes during pregnancy.
The anti-oxidant Selenium (Se) suppresses autoimmune destruction of thyrocytes and at daily dose of 200 mcg and 100 mcg decreases titers of serum TPOAb and TgAb also in Se-non-deficient patients with autoimmune thyroiditis (AIT).
The use of Se in AIT has been shown to reduce the incidence of postpartum thyroiditis and hypothyroidism.
Women with recurrent pregnancy loss had lower Se levels and Se deficiency has been implicated in the pathogenesis of AIT and in the impairment of T/B cell-mediated immunity.
The purpose of the present study is performed to establish the effect of Se supplementation in euthyroid women with AIT (pregnant and in whom embryo transfer is expected within 60 days) on Ab trend, thyroid function and structure, implantation rates, pregnancy rates, pregnancy outcome and number of obstetrical, fetal and neonatal complications.
Adverse outcomes, postpartum thyroid dysfunction and permanent hypothyroidism have been associated with isolated TPOab positivity in euthyroid pregnant women.
In areas with severe selenium deficiency there is a higher incidence of thyroiditis due to a decreased activity of selenium-dependent glutathione peroxidase activity within thyroid cells. Selenium-dependent enzymes also have several modifying effects on the immune system. Therefore, even mild selenium deficiency may contribute to the development and maintenance of autoimmune thyroid diseases.
Selenium substitution exerts anti-inflammatory and anti-oxidant activities. Se could represents an important supplementation in euthyroid women with AIT in order to improve thyroid function and structure and to prevent obstetrical adverse events related to autoimmune diseases and reactive oxygen species, such as recurrent miscarriage and pre-eclampsia.
The aim of this study is to document the effects of Selenium Supplementation with and without L-thyroxine (LT4) in euthyroid women with AIT, during pregnancy.
This protocol will evaluate the trend of TPOab and Tgab, selenium concentration, thyroid volume and echogenicity, nodule formation and number of adverse effects that affect the mother (during and after pregnancy), the fetus, the infant and the heath service, needing to elucidate the nature of the emerging associations.
The study also aims to assess the impact of Selenium Supplementation on implantation rate and pregnancy rate in women with transfer planned within the next 60 days.
This is designed as a phase IV study on treatment with a cohort size of pregnant women and women in whom embryo transfer is expected within 60 days with TSH value into the normal range (0.4-2.5 mUI/mL) and Tgab and/or TPOab positivity. We have performed two randomizations arms: Randomization arm A will include women LT4 replacement-free that will take Selenium or Placebo and Randomization arm B will include women already under LT4 replacement that will take Selenium or Placebo. Patients included in Randomization A will move into Randomization B, if TSH increases above 2.5 mUI/mL during pregnancy.
Pregnant women with TSH > 2.5 mU/mL at time 0 will begin (or will adjust) LT4 replacement and will be included in Randomization arm B.
Accounting for a 30% drop off, a total enrolment of 150 patients is planned. Patients will be randomized at time 0 (10°± 2 weeks of gestation). Follow-up visits will take place at weeks 14 ± 2, 24 ± 2, 32 ± 2, 36 ± 2 weeks, and between months 3° and 6° after labour. An optional visit could be done 12 months after labor. Plasma and serum monitoring of thyroid hormones, Tgab, TPOab, Se concentration, Selenoproteins and cytokines, thyroid US, SF12 questionnaire will be made at all the follow-up visits. At visit 3 (24 ± 2 weeks) patients will optionally do the OGTT). Gestational, obstetrical, maternal, fetal, and infant anamnestic data will be taken, during the follow up visits and at labour.
The long-term objective is to identify a safe and easily administered supplementation that improves:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Selenium
Other: Sugar Pill Placebo
Other: Selenium + L-Thyroxine (LT4)
Other: Sugar Pill Placebo + L-Thyroxine (LT4)
83 micrograms of selenium (in the form of selenium methionine) in tablet form taken orally daily for all the length of pregnancy and for 3-6th month after labour
Also known as: Intervention I (Se)
Placebo supplements in the same capsule as selenium. 1 tablet daily for all the length of pregnancy and for 3-6th month after labour.
Also known as: Intervention II (Plb)
83 micrograms of selenium (in the form of selenium methionine) in tablet form taken orally daily for all the length of pregnancy and for 3-6th month after labour + LT4 taken orally daily according to the dose required(in women already receiving it or needing of start it)
Also known as: Intervention III (Se+LT4)
Placebo supplements in the same capsule as selenium. 1 tablet daily for all the length of pregnancy and for 3-6th month after labour + LT4 taken orally daily according to the dose required(in women already receiving it or needing of start it)
Also known as: Intervention IV (Plb + LT4)
Changes in TPOab and/or Tgab
TPOab and Tgab titers will be measured using a ECLIA kit. Plasma selenium concentration will also be measured
Time frame: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour
Changes in thyroid volume and echogenicity
Also changes in thyroid nodules diameters and/or nodules formation will be measured by Ultrasonographic (US) imaging
Time frame: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour
Changes in thyroid hormones (TSH, FT4, FT3)
Time frame: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour
Evaluation of Maternal risks
Pre-eclampsia (gestational hypertension: systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg \[Korotkoff V\] on ≥ 2 occasions after 20 weeks gestation), Miscarriage, Placental Abruption, Abruption, Gestational hypertension, Breech presentation at birth, Preterm birth (\< 37 weeks gestation), Symptomatic hypothyroidism, Preterm labour, Postpartum haemorrhage, Postpartum depression, Postpartum Thyroiditis, Maternal death
Time frame: From the date of randomization until the date of first documented event
Evaluation of Infant risks
Small for gestational age, Admission to special care, Cretinism, Jaundice requiring phototherapy, Poor feeding, Constipation, Hoarse cry, Lethargy, Hypotonia, Macroglossia, Umbilical hernia
Time frame: From the date of labour until the date of the first documented event
Changes in of quality of life
Quality of life will be measured by questionnaire SF12
Time frame: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour
Evaluation of Health Services:
Maternal length of hospital stay (days), Neonatal length of hospital stay (in days), Cost of services
Time frame: from the date of admission until the date of discharge
Changes in the selenium-dependent antioxidant enzyme glutathione peroxidase
Glucose, Vitamin B-12, folate, methionine, albumin and cytokines will be also measured in serum
Time frame: 0, 24 ± 2, 36± 2 weeks; and 6 months after labour
Changes in implantation and pregnancy rates
Clinical implantation rate (IR) and pregnancy rate (PR)
Time frame: From the date of embryo transfer until the date of documented progression
The record gives a start of Apr 2012, a primary completion of Jun 2017 and a completion of Jan 2018. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Selenium
University of Roma La Sapienza →