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Abortion, HabitualPhase 3LIGHTNCT06999278

LIGHT Trial: Levothyroxine for Gestational Hypothyroidism in Recurrent Pregnancy Loss

A Phase 3 study testing Levothyroxin in people with Abortion, Habitual, run by Women's Hospital School Of Medicine Zhejiang University at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether levothyroxine supplement improves pregnancy outcomes in women with recurrent pregnancy loss (RPL) and isolated maternal hypothyroidism (IMH). Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Abortion, Habitual
What is being tested?
Levothyroxin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
2 sitesChina
Study dates
1 Jun 2025to 31 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • women with singleton pregnancy
  • women with a history of recurrent pregnancy loss (defined as two or more pregnancy loss before 20wks)
  • women diagnosed with isolated maternal hypothyroidism (defined as isolated lower level of FT4 with normal TSH levels) in the current pregnancy before 20wks

Who cannot join

  • patients with known thyroid disorders
  • patients with antiphospholipid syndrome or other autoimmune conditions
  • patients with contraindications to levothyroxine (e.g., acute cardiac arrest, acute pancreatitis, acute myocarditis)
  • patients attending other ongoing clinical trials or unwilling to participate.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qiong Luo, Ph.D. contact

+86 571 89998819

luoq@zju.edu.cn

Zixing Zhong, MSc contact

+86 571 85893328

zhongzixing@hmc.edu.cn

China2 sites

  • Zhejiang Women's Hospital

    Hangzhou, Zhejiang, 310006

    Wen Hu, +86571-87061501, huwen1116@zju.edu.cn

    Qiong Luo, Ph.D.

  • Zhejiang People's Hospital

    Hangzhou, Zhejiang, 310014

    Zixing Zhong, MSc, 13758145829, zhongzixing@hmc.edu.cn

    Feifei Zhou, MSc

Other trials in China

About this study

Official title: LIGHT - Levothyroxine for Isolated Gestational HypoThyroidism in Women With Recurrent Pregnancy Loss: a Multicenter Randomized, Double-blind, Placebo-controlled Trial - a Study Protocol

The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether levothyroxine supplement improves pregnancy outcomes in women with recurrent pregnancy loss (RPL) and isolated maternal hypothyroidism (IMH).

The main questions it aims to answer are:

Read more

Does levothyroxine increase the live birth rate after 24 weeks of gestation? Does levothyroxine improve secondary outcomes such as ongoing pregnancy rates, reduce the incidence of pregnancy loss, or influence maternal and neonatal complications?

Researchers will:

Compare the levothyroxine treatment group (50 µg/day) to the placebo group to assess the impact of the intervention on live birth rates and other pregnancy outcomes.

Participants will:

Be randomly assigned to receive either levothyroxine or a placebo. Take the assigned treatment daily starting from enrollment until the end of pregnancy.

Undergo routine follow-up visits to monitor pregnancy progress and outcomes. This trial seeks to determine whether routine levothyroxine supplementation can improve pregnancy outcomes for women with RPL and IMH.

Read the detailed description

Investigators will perform a multi-center, randomized, placebo, double-blind clinical trial of levothyroxine (LT4) in patients aged between 18 years and 40 yearls who are diagnosed with isolated hypothyroxemia (defined as lower FT4 level with normal TSH) and have a previous history of recurrent miscarriages (defined as two or more pregnancy loss). Investigators will assess the effects of standard dose of 50ug/d levothyroxine therapy from the day after randomization to the day of delivery on the pregnancy outcomes, including live birth, neonatal complications, and adverse pregnancy outcomes, etc.

Being tested
Levothyroxin, Placebo
Keywords
recurrent pregnancy loss, isolated maternal hypothyroidism, levothyroxine, adverse pregnancy outcomes, live birth, neonatal complications
Medical subject headings
Abortion, Habitual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevothyroxinDrug

    Levothyroxin 50ug/d from randomization until delivery

  • PlaceboDrug

    Placebo to levothyroxin

Study groups in NCT06999278
Study groupRoleWhat they receive
Arm LT4ExperimentalThe intervention will consist of standard treatment with levothyroxine tablets (50ug/day). The treatment will start from the next day after randomization and end at the day of delivery.
Receives: Drug: Levothyroxin
Arm PlaceboPlacebo comparatorThe intervention will consist of standard treatment with levothyroxine placebo daily. The treatment will start from the next day after randomization and end at the day of delivery.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live birth after 28 weeks of gestation

    Live birth following spontaneous labor or iatrogenic delivery after 28+0 weeks of gestation (196 days from the participant's last menstrual period)

    Measured: From the enrollment to the day of delivery after 28+0 weeks of gestation

Secondary outcomes (16)

  1. Ongoing pregnancy at 7 weeks of gestation

    ultrasound diagnosis of ongoing pregnancy at 7 weeks of gestation

    Measured: From the day of randomization to the 7 weeks of gestation

  2. Ongoing pregnancy at 12 weeks of gestation

    ultrasound diagnosis of ongoing pregnancy at 12 weeks of gestation

    Measured: From the day of randomization to the 12 weeks of gestation

  3. Ongoing pregnancy at 24 weeks of gestation

    ultrasound diagnosis of ongoing pregnancy at 24 weeks of gestation

    Measured: From the day of randomization to the 24 weeks of gestation

  4. Miscarriage

    pregnancy loss before 20 weeks of gestation

    Measured: From enrollment to 19+6 weeks of gestation

  5. Stillbirth

    fetal death delivered beyond 20 weeks of gestation

    Measured: From enrollment to the day of delivery of the dead fetus from 20+0 weeks onward

  6. Ectopic pregnancy

    ultrasound diagnosis of ectopic pregnancy

    Measured: From enrollment to the end of treatment up to 20 weeks

  7. Abortion

    personal request the termination of pregnancy without medical conditions

    Measured: From enrollment to the day of termination of pregnancy up to 27+6 weeks

  8. Need for cervical cerclage

    medically indicated cervical cerclage up to 27+6 weeks of gestation

    Measured: From enrollment to the day of cervical cerlage performed up to 27+6 weeks

  9. Preterm birth

    live birth between 28+0 and 36+6 weeks of gestation

    Measured: From enrollment to the day of preterm birth between 28+0 and 36+6 weeks

  10. Gestational age at delivery

    Gestational age at delivery

    Measured: up to delivery

  11. Antepartum complications

    including: preeclampsia, gestational diabetes, fetal growth restriction

    Measured: From enrollment to the day of delivery, up to 42+0 weeks

  12. Intrapartum complications

    including: fetal distress, dystocia, fever

    Measured: up to delivery

  13. Postpartum complications

    including: postpartum hemorrhage, infection, fever

    Measured: up to 42 days after childbirth

  14. Neonatal birthweight

    the birthweight of the neonate: unit (kg)

    Measured: up to delivery

  15. Neonatal APGAR score

    Neonatal APGAR score at 1 and 5 minutes

    Measured: up to 5 minutes after delivery

  16. Neonatal complications

    include neonatal breathing disorders, neonatal infections, neonatal asphyxia, neonatal jaundice, NICU admission for any other causes

    Measured: up to 7 days after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multi-center, randomized, double-blind, placebo-controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06999278
Sponsor's protocol ID
IRB-20250069-R
Acronym
LIGHT
Status last verified
May 2025
First submitted
19 Mar 2025
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: individual participant data may be made available at reasonable request on the principal investigator.

Publications

  • Dhillon-Smith RK, Middleton LJ, Sunner KK, Cheed V, Baker K, Farrell-Carver S, Bender-Atik R, Agrawal R, Bhatia K, Edi-Osagie E, Ghobara T, Gupta P, Jurkovic D, Khalaf Y, MacLean M, McCabe C, Mulbagal K, Nunes N, Overton C, Quenby S, Rai R, Raine-Fenning N, Robinson L, Ross J, Sizer A, Small R, Tan A, Underwood M, Kilby MD, Boelaert K, Daniels J, Thangaratinam S, Chan SY, Coomarasamy A. Levothyroxine in Women with Thyroid Peroxidase Antibodies before Conception. N Engl J Med. 2019 Apr 4;380(14):1316-1325. doi: 10.1056/NEJMoa1812537. Epub 2019 Mar 23.

    PubMed 30907987

  • van Dijk MM, Vissenberg R, Fliers E, van der Post JAM, van der Hoorn MP, de Weerd S, Kuchenbecker WK, Hoek A, Sikkema JM, Verhoeve HR, Broeze KA, de Koning CH, Verpoest W, Christiansen OB, Koks C, de Bruin JP, Papatsonis DNM, Torrance H, van Wely M, Bisschop PH, Goddijn M. Levothyroxine in euthyroid thyroid peroxidase antibody positive women with recurrent pregnancy loss (T4LIFE trial): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2022 May;10(5):322-329. doi: 10.1016/S2213-8587(22)00045-6. Epub 2022 Mar 14.

    PubMed 35298917

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levothyroxin in people with Abortion, Habitual, run by Women's Hospital School Of Medicine Zhejiang University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qiong Luo, Ph.D. (+86 571 89998819, luoq@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live birth after 28 weeks of gestation (time frame: From the enrollment to the day of delivery after 28+0 weeks of gestation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06999278, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.

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