An observational study in Subclinical Hypothyroidism, Infertility and Assisted Reproductive Technology, sponsored by Mỹ Đức Hospital. Recruiting at 2 sites in Vietnam. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Mỹ Đức Hospital · Observational
Among 13 studies in Infertility by Mỹ Đức Hospital — 5 open to participants now, 5 under way, none of them phase 3. Infertility · Mỹ Đức Hospital.
Among the 13 studies in Infertility by Mỹ Đức Hospital, this one is the 2nd largest by planned enrollment of the 10 observational ones, is one of 3 that started in 2019, is one of 10 observational ones, and was the 10th registered.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 900 is above the median of 200 across 592 observational studies indexed under Infertility.
Browse Infertility studies →5 of the 13 studies in Infertility by Mỹ Đức Hospital 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 45 Years · female · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 3 started in 2019.
Median enrollment 1,064 across the 3 interventional studies, 320 across the 10 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
Mỹ Đức Hospital is the lead sponsor of 56 studies on the registry; 21 are open to participants now.
2 of the studies in Infertility by Mỹ Đức Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07358468Mỹ Đức HospitalAssociation Between Peri-Transfer Endometrial Peristalsis And Live Birth In Modified Natural Cycle Frozen Embryo Transfer: A Prospective Cohort Study | 2026-12-01 |
| NCT07675213Mỹ Đức HospitalEndometrial Peristalsis and Pregnancy Outcomes in Hormone Replacement Therapy (HRT) - Frozen Embryo Transfer (FET) Cycles | 2027-06-01 |
Among the 13 studies in Infertility by Mỹ Đức Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
This study is a target trial specified (a randomized controlled trial between the Intervention (Exposed) Group and the Control (Unexposed) Group).
The target trial is emulated using observational data of infertile women aged 18-45 years diagnosed with subclinical hypothyroidism, defined as TSH 4.2-\<10 mIU/L and FT4 0.92-1.68 ng/dL, undergoing IVF/ICSI followed by FET in My Duc Hospital and My Duc Phu Nhuan Hospital (Ho Chi Minh City, Vietnam), using routinely collected medical records from January 1, 2019, to December 31, 2024.
Infertile women aged 18-45 years diagnosed with subclinical hypothyroidism (TSH 4.2-\<10 mIU/L, normal FT4) who underwent IVF/ICSI with subsequent frozen embryo transfer (FET) at My Duc Hospital and My Duc Phu Nhuan Hospital, Ho Chi Minh City, Vietnam, between 2019 and 2024.
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:
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.
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.
Live birth rate after the first frozen embryo transfer (FET) cycle
Delivery of a neonate showing any sign of life (heartbeat, umbilical cord pulsation, or movement) at ≥ 22 weeks' gestation after the nearest frozen embryo transfer cycle performed following levothyroxine treatment (or no treatment) in women with subclinical hypothyroidism undergoing IVF/ICSI.
Time frame: At delivery (within approximately 9 months after embryo transfer)
Positive pregnancy test rate
Serum β-hCG ≥ 25 IU/mL after embryo transfer.
Time frame: 10-14 days post-transfer
Clinical pregnancy rate
Ultrasonographic visualization of a gestational sac or embryo with cardiac activity.
Time frame: 6 weeks post-transfer
Ongoing pregnancy rate
Presence of a fetus with heartbeat at ≥ 12 weeks' gestation.
Time frame: 12 weeks post-transfer
Implantation rate
Number of gestational sacs divided by number of embryos transferred.
Time frame: 3 weeks post-transfer
Miscarriage rate
Spontaneous loss of a clinical pregnancy before 22 weeks' gestation.
Time frame: Up to 22 weeks post-transfer
Ectopic pregnancy rate
Pregnancy outside the uterine cavity confirmed by ultrasound or surgery.
Time frame: Up to 6 weeks post-transfer
Multiple pregnancy rate
Detection of ≥2 gestational sacs on ultrasound.
Time frame: 6 weeks post-transfer
Preterm birth rate
defined as a birth that takes place after 22 weeks and before 37 completed weeks of gestational age.
Time frame: At delivery
Gestational hypertension/preeclampsia
Gestational hypertension/preeclampsia is defined as the development of hypertension with or without proteinuria after 20 weeks of gestation.
Time frame: After 20 weeks' gestation
Gestational diabetes mellitus
Gestational diabetes mellitus is diagnosed by 75-g Oral Glucose Tolerance Test (OGTT) with abnormal fasting or postload glucose at 24-28 weeks.
Time frame: 24-28 weeks' gestation
Neonatal birthweight
Infant weight at delivery (low \<2500 g; very low \<1500 g; high \>4000 g).
Time frame: At delivery
Congenital anomalies
Congenital anomalies are defined as structural or functional disorders that occur during intra-uterine life and can be identified prenatally at birth.
Time frame: at delivery
Neonatal death
Death of a live-born infant within 28 days of birth.
Time frame: Up to 1 month after delivery
Not enrolling at this site.
Plan to share: No
Ran from Jan 2019 to primary completion in Dec 2024, 71 months.
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