Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:31 AM
Study NCT ID:
NCT07449260
Status:
COMPLETED
Last Update Posted:
2026-03-10
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Serum Thyroid-stimulating Hormone (TSH) and Intracytoplasmic Sperm Injection (ICSI) Outcome in Women Undergoing ICSI
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Is TSH Level in Serum Affect ICSI Outcome?
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: