Infertility, FemaleNCT07449260
Association Between Serum Thyroid-stimulating Hormone (TSH) and Intracytoplasmic Sperm Injection (ICSI) Outcome in Women Undergoing ICSI
An observational study of Infertility, Female, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Basal TSH level
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Infertile women attended at El Kasr Al Ainy IVF unit
Who may be able to join
- 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
Who cannot join
- Women with polycystic ovary syndrome (PCOS).
- Poor ovarian response.
- Severe teratoathenospermia.
- women with chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- Basal TSH level
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basal TSH levelOther
On day 2-3 of spontaneous cycles, all planned women for ICSI cycle had basal TSH level measurment
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients with TSH<2.5 miu/L Receives: Other: Basal TSH level | |
| Group B | Patients with TSH 2.5-4 miu/L Receives: Other: Basal TSH level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 4years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Jan 2019
- Primary completion1 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mostafa Mohammed Refaay El shemy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449260
- Sponsor's protocol ID
- TSH and ICSI
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is TSH Level in Serum Affect ICSI Outcome?
- ClinicalTrials.gov ID
- NCT07449260
- Acronym / sponsor ID
- TSH and ICSI
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Basal TSH levelPatients with TSH<2.5 miu/L |
| Group B | – | Other: Basal TSH levelPatients with TSH 2.5-4 miu/L |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Infertile women attended at El Kasr Al Ainy IVF unit
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Women with polycystic ovary syndrome (PCOS).
- Poor ovarian response.
- Severe teratoathenospermia.
- women with chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basal TSH levelOn day 2-3 of spontaneous cycles, all planned women for ICSI cycle had basal TSH level measurment | Other | Group A, Group B |
Primary outcome
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 .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICSI outcome and its relation with TSH level (time frame: 4years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.