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Association Between Serum Thyroid-stimulating Hormone (TSH) and Intracytoplasmic Sperm Injection (ICSI) Outcome in Women Undergoing ICSI

Is TSH Level in Serum Affect ICSI Outcome?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07449260
Enrollment
180
Registered
2026-03-04
Start date
2019-01-01
Completion date
2025-02-01
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female

Brief summary

TSH has been suggested to be involved in reproductive challenges such as ovulatory issues, infertility, miscarriage, and maternal complications for many years. Multiple studies have associated thyroid function with ovarian function and reproductive physiology. The thyroid hormone can impact follicle development, as well as the metabolism of estrogen and androgen, the menstrual cycle, and the receptivity of the endometrium

Detailed description

In a region with adequate iodine levels, a TSH threshold of 4.12 mIU/L should be regarded as the upper limit of normal. The Chinese Society for Reproductive Medicine suggests that infertile women and those trying to conceive should consider a TSH level between 4-4.5 mIU/L for subclinical hypothyroidism. Hence, it is recommended that women aiming for in vitro fertilization (IVF) should have a TSH level of 4 mIU/L or lower. Studies have shown that infertile patients with untreated TSH levels \>2.5 mIU/L before IVF/intracytoplasmic sperm injection (ICSI) had better pregnancy results when their TSH levels were \<2.5 mIU/L compared to those with TSH \>2.5 mIU/L. In this study the aim was to Examine the clinical characteristics and results in infertile individuals with varying thyroid stimulating hormone (TSH) levels during ICSI, and determining which TSH levels cutoff impact the outcomes of ICSI or not.

Interventions

OTHERBasal TSH level

On day 2-3 of spontaneous cycles, all planned women for ICSI cycle had basal TSH level measurment

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Body mass index (BMI): women with BMI 18 : 30 kg/m2. * Favorable (average) responders to IVF stimulation: Anti-mullirian hormone (AMH) level \>1.0 ng/mL but \<3.5 ng/mL and antral follicular count (AFC) 5-10. * The embryos were transferred freshly or frozen . * Medically free

Exclusion criteria

* Women with polycystic ovary syndrome (PCOS). * Poor ovarian response. * Severe teratoathenospermia. * women with chronic disease

Design outcomes

Primary

MeasureTime frameDescription
ICSI outcome and its relation with TSH level4yearsNumber of oocyte retrieved , percentage of fertilization rate, cleavage rate, available embryo rate, pregnancy rate analyzed to explore whether serum TSH level in miu/L affect ourtcome or not .

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026