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

March 6, 2026 updated by: Shaimaa Mostafa Mohammed Refaay El shemy, Cairo University

Is TSH Level in Serum Affect ICSI Outcome?

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Giza, Cairo Governorate, Egypt, 4240310
        • Shaimaa El Shemy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Infertile women attended at El Kasr Al Ainy IVF unit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Patients with TSH<2.5 miu/L
Other: Basal TSH level
On day 2-3 of spontaneous cycles, all planned women for ICSI cycle had basal TSH level measurment
Group B
Patients with TSH 2.5-4 miu/L
Other: Basal TSH level
On day 2-3 of spontaneous cycles, all planned women for ICSI cycle had basal TSH level measurment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
4years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSH and ICSI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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