Effectiveness of Levothyroxine Treatment on In Vitro Fertilization and Pregnancy Outcome in Women With Subclinical Hypothyroidism and Infertility: A Target Trial Emulation

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY

Subclinical hypothyroidism (SCH) is defined by elevated thyroid-stimulating hormone (TSH) with normal free thyroxine (fT4) levels. It affects approximately 5-7% of women of reproductive age and may negatively influence outcomes of assisted reproductive technology (ART). During controlled ovarian stimulation, rising estradiol increases thyroxine-binding globulin and thyroid hormone requirements. These physiological changes, combined with increased metabolic demand in early pregnancy, may worsen SCH and contribute to adverse outcomes such as miscarriage, preterm birth, and hypertensive disorders of pregnancy. Although levothyroxine (LT4) is routinely used to treat overt hypothyroidism, evidence for its benefit in SCH, especially among infertile women undergoing In Vitro Fertilization (IVF) or Intra-Cytoplasmic Sperm Injection (ICSI) with frozen embryo transfer (FET), remains inconclusive. Some trials and meta-analyses have shown reductions in miscarriage and neonatal mortality, while others have found no improvement in ART or obstetric outcomes. This study aims to evaluate the effectiveness of levothyroxine therapy on IVF/FET outcomes and subsequent pregnancy results in women with subclinical hypothyroidism and infertility. This retrospective cohort study will emulate the target trial to evaluate whether LT4 treatment, titrated to achieve a pre-transfer TSH \< 2.5 mIU/L, improves implantation, live birth, and obstetric outcomes compared with expectant management.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Viet Nam
My Duc Hospital
RECRUITING
Ho Chi Minh City
My Duc Hospital
COMPLETED
Ho Chi Minh City
Contact Information
Primary
Hoanh Kieu Tran, Doctor
trankieuhoanh@myduchospital.vn
+84 982 741 425
Backup
Lan Thi Ngoc Vuong, Assoc. Prof.
drlan@yahoo.com.vn
+84 901 183 918
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 900
Treatments
Levothyroxine-Treated Group
Women with subclinical hypothyroidism (TSH 4.2-\<10 mIU/L, normal FT4) treated with levothyroxine 25-50 µg/day before frozen embryo transfer (FET). The dose was adjusted every 2-4 weeks to achieve a pre-transfer TSH \<2.5 mIU/L. Outcomes including implantation, pregnancy, and live birth rates were assessed after the nearest post-treatment FET cycle.
Non-Treated (Control) Group
Women with subclinical hypothyroidism (TSH 4.2-\<10 mIU/L, normal FT4) who did not receive levothyroxine treatment prior to frozen embryo transfer. Participants were managed expectantly according to clinical judgment. Outcomes were compared with those of the treated group for IVF/ICSI-FET success and pregnancy results.
Related Therapeutic Areas
Sponsors
Leads: Mỹ Đức Hospital

This content was sourced from clinicaltrials.gov