Trial reportFertility and sterility2025
A relook at the relevance of thyroid stimulating hormone and thyroid autoimmunity for pregnancy outcomes: Analyses of randomized control trials data from Pregnancy in Polycystic Ovary Syndrome and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation.
Trial report in Fertility and sterility, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A 20 Week Double-Blind Randomized Trial of Clomiphene Citrate and Letrozole for the Treatment of Infertility in Women With Polycystic Ovary Syndrome
Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation
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Authors and funding
8 authors.
Funding
Abstract
objectiveWe examined if thyroid autoimmunity is relevant to the relationship between maternal thyroid stimulating hormone (TSH) levels and pregnancy outcomes.
designRetrospective cohort analysis of data from 2 randomized controlled trials (RCTs). SUBJECTS: Participants of the Pregnancy in Polycystic Ovary Syndrome (PPCOS II, n = 746) and the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS, n = 832 with unexplained infertility) RCTs. EXPOSURE: Pre-RCT intervention levels of TSH at threshold of ≥2.0 mU/L and thyroid peroxidase antibody (TPO-Ab) at titer threshold of ≥30 U/mL.
main outcome measuresLive birth (primary outcome), pregnancy loss, and preterm birth (secondary outcomes). Generalized linear model (GLM) analyses examined the relationship between exposure to TSH and TPO-Ab at specified thresholds with the specified outcomes; covariates adjusted for included age, body mass index, race, ethnicity, education, smoking, duration of infertility, PCOS (vs. unexplained infertility), and randomized intervention arm in the respective RCTs.
resultsOn adjusted analyses, live birth was significantly reduced in the exposed population (those with TSH ≥2.0 mU/L and TPO-Ab ≥30 U/mL, n = 117/1,578, 7.4%, adjusted risk ratio [ARR]: 0.55; 95% CI: 0.35-0.87) compared with the unexposed (those with TSH <2.0 mU/L and TPO-Ab <30 U/mL, n = 865/1,578, 54.8%). Furthermore, the risk of pregnancy loss and of early preterm birth (<32 weeks) was significantly higher in the exposed compared with the unexposed (ARR for pregnancy loss was 1.66; 95% CI: 1.14-2.42, and ARR for early preterm birth was 4.82, 95% CI: 1.53-15.19).
conclusionIn women with TPO-Ab titers ≥30 U/mL, pregnancy outcomes may be compromised at TSH threshold of ≥2 mU/L. These findings of an interaction between TSH and TPO for pregnancy outcomes merit further investigation in prospective studies. TRIAL REGISTRATION NUMBER: NCT00719186 and NCT01044862.
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