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

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

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Shaimaa El Shemy

Giza, Cairo Governorate, 4240310, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basal TSH level

Other

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

Primary outcomes

ICSI outcome and its relation with TSH level

Time frame: 4years

Number 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 .

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Is TSH Level in Serum Affect ICSI Outcome?

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2025
First posted: Mar 4, 2026
Registry last updated: Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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