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

NCT07449260 | Completed

• 1 other identifier: TSH and ICSI
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• ICSI outcome and its relation with TSH level

  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

Study Arms (2)

Group A

Patients with TSH\<2.5 miu/L

Other: Basal TSH level

Group B

Patients with TSH 2.5-4 miu/L

Other: Basal TSH level

Interventions

Basal TSH level OTHER

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

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Infertile women attended at El Kasr Al Ainy IVF unit

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Shaimaa El Shemy

Giza, Cairo Governorate, 4240310, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: January 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)