Levothyroxine for women with mild (subclinical) hypothyroidism having IVF/ICSI and frozen embryo transfer
Official title: Effectiveness of Levothyroxine Treatment on In Vitro Fertilization and Pregnancy Outcome in Women With Subclinical Hypothyroidism and Infertility: A Target Trial Emulation
Run by Mỹ Đức Hospital · NCT07257250 · Data updated 2026-11-12
This project will try giving low‑dose levothyroxine to women with subclinical hypothyroidism undergoing IVF/ICSI with frozen embryo transfer to see if it improves pregnancy outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 900 (estimated) |
| Sponsor | Mỹ Đức Hospital Academic / other |
| Locations | 2 sites (Ho Chi Minh City, Ho Chi Minh and 1 other locations) |
| Status | Recruiting |
| Started | January 1, 2019 |
| Main results expected | December 30, 2024 |
| Study ends | March 30, 2026 |
| Registry record updated | January 14, 2026 |
| Trial ID | NCT07257250 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–45 with subclinical hypothyroidism (TSH 4.2–<10 mIU/L and FT4 within the normal range) who are undergoing IVF or ICSI followed by frozen embryo transfer and receiving care at the participating My Duc centers.
✕Probably not a fit
Patients with overt hypothyroidism (TSH ≥10 mIU/L or low FT4), those already on levothyroxine or other thyroid‑active drugs within the prior month, or those whose infertility is unrelated to thyroid status may not derive additional benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The analysis emulates a randomized target trial using routinely collected records from My Duc Hospital and My Duc Phu Nhuan Hospital in Ho Chi Minh City between 2019 and 2024. Eligible women are 18–45 years old with subclinical hypothyroidism (TSH 4.2–<10 mIU/L and normal FT4) who underwent IVF/ICSI followed by frozen embryo transfer. The exposed group received levothyroxine 25–50 µg/day started before planned FET and titrated every 2–4 weeks to reach TSH <2.5 mIU/L, while the unexposed group was managed expectantly; timing and lab targets are used to emulate random assignment. Outcomes of interest include implantation, miscarriage, preterm birth, hypertensive disorders, and live birth, with statistical methods to account for confounding by indication.
Why it matters
Potential benefit: If successful, this approach could reduce miscarriage and improve live birth rates for women with subclinical hypothyroidism undergoing IVF/ICSI with frozen embryo transfer.
How similar studies have gone: Previous randomized trials and meta‑analyses have reported mixed results—some showing reductions in miscarriage or neonatal mortality with levothyroxine in mild thyroid dysfunction, but overall evidence remains inconclusive for improving IVF outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 18-45 years. * Diagnosed with subclinical hypothyroidism (TSH 4.2-\<10 mIU/L with FT4 0.92-1.68 ng/dL). * Undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) followed by frozen embryo transfer (FET). Exclusion Criteria: * Overt hypothyroidism (TSH ≥10 mIU/L and FT4 ≤0.92 ng/dL). * Current or recent (within 1 month) use of drugs affecting thyroid function (levothyroxine, amiodarone, methimazole, propylthiouracil).
Where it's running
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My Duc Hospital
Ho Chi Minh City, Ho Chi Minh, Vietnam Recruiting -
My Duc Hospital
Ho Chi Minh City, Ho Chi Minh, Vietnam Completed
Study contacts
- Study coordinator: Hoanh Kieu Tran, Doctor
- Email: trankieuhoanh@myduchospital.vn
- Phone: +84 982 741 425
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Endometrial Waves and Pregnancy in FET Cycles with Hormone Therapy
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This study is testing whether using artificial intelligence can help doctors better predict the success of IVF treatments by analyzing patient data and ultrasound images.
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AI-assisted embryo selection on day 5 in IVF for infertility
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.