Hypothyroidism and Infertility-

An intriguing link

IND2301328 09 Jan 2024

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Case Study 1

Case Presentation :- A 26‐year woman with inability to conceive for 1.5 years. She had no relevant medical history.
Family History :- Father was on treatment for hyperthyroidism.

On examination :- BMI : 24.3 kg/m2, and BP : 90/60 mm Hg.

Ultrasound neck :- Revealed normal thyroid gland volume with heterogeneous hypoechoic pattern.

Lab Investigation Results Reference Range

TSH 5.66 mIU/mL 0.39‐4.16 mIU/L

FT4 1 ng/dL 0.8‐2 ng/dL

FT3 2.4 pg/mL 1.4‐4.2 pg/mL
TPOAb > 600 IU/mL 0‐40 IU/mL

Allam MM, El‐Zawawy HT, Barakat SS, Ahmed SM, Saleh RNM. A hidden cause of infertility in hypothyroid patients. Clinical Case Reports 2020;8:374–8. https://doi.org/10.1002/ccr3.2654.
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Case Study 1

Diagnosis :- Hashimoto's thyroiditis with subclinical hypothyroidism.

Management :- LT4 (75 mcg/d). After 3 months, her test results showed: TSH = 1.32 μIU/mL (<2.5 mIU/L),
FT4 = 1.29 ng/dL, FT3 = 2.7 pg/mL.

The patient conceived after three failed trials. Miscarriage at 15 th Gestational week.

Hormonal Profile Post Results Reference Range

Managenent
FSH 5.8 mIU/mL 3.5‐12.5 mIU/mL
LH 6.6 mIU/mL 2.6‐12.6 mIU/mL
PRL 8 ng/mL 2‐18 ng/mL
AMH 4 ng/mL Optimal Fertility
1.68‐4.4 ng/mL

Allam MM, El‐Zawawy HT, Barakat SS, Ahmed SM, Saleh RNM. A hidden cause of infertility in hypothyroid patients. Clinical Case Reports 2020;8:374–8. https://doi.org/10.1002/ccr3.2654.
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Case Study 2
Case Presentation :- A 24-year-old woman who had a six‐year‐old child, was unable to conceive for 2 years.
Induction of ovulation using clomiphene citrate failed five times, despite good ovarian response.

History :- Chronic allergic rhinitis. Maintained on LT4 100 μg. Menorrhagia for 6 years.

On examination :- BMI: 32.3 kg/m2 and BP: 90/60 mm Hg.

USG Neck :- Normal thyroid gland volume with heterogeneous hypoechoic pattern.

Lab Investigation Norm Values Results

TSH 0.39‐4.16 mIU/L 3.6 mIU/mL

FT4 0.8‐2 ng/dL 1.1 ng/dL

FT3 1.4‐4.2 pg/mL 2.7 pg/mL

TPOAb 0‐40 IU/mL > 1950 IU/mL

Allam MM, El‐Zawawy HT, Barakat SS, Ahmed SM, Saleh RNM. A hidden cause of infertility in hypothyroid patients. Clinical Case Reports 2020;8:374–8. https://doi.org/10.1002/ccr3.2654.
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Case Study 2

Diagnosis : Hypothyroid due to Hashimoto's thyroiditis 3 years ago.

Management : LT4 was titrated till reaching a dose of 125 mcg/d. After 3 months, TSH = 0.92 μIU/mL,
FT4 = 1.69 ng/dL, and FT3 = 2.7 pg/mL.

In spite of maintaining a TSH level below 2.5, the patient still did not conceive. Two failed IVF cycles, with nine
metaphase II oocytes injected, six oocytes fertilized, and a total of two embryos transferred.

During all the IVF attempts managed with Dehydroepiandrosterone 25 mg TID and a high (5 mg/d) dose of
folic acid.

[1] Allam MM, El‐Zawawy HT, Barakat SS, Ahmed SM, Saleh RNM. A hidden cause of infertility in hypothyroid patients. Clinical Case Reports 2020;8:374–8. https://doi.org/10.1002/ccr3.2654.
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Hypothyroidism and Infertility

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 Introduction

● Infertility is defined as the inability to conceive after 1 year of regular intercourse

without contraception. The prevalence of infertility is estimated between 12 and 14%
and has remained stable in recent years.

● Male and female partners alone are responsible

for 20–30% of cases, respectively, but contribute to 50% of
cases overall.
● female infertility including endometriosis, tubal disorders and ovulatory dysfunction
is present in 35% of all infertile couples.
● Thyroid autoimmunity is significantly increased in these women and especially in
women with endometriosis compared with fertile women of reproductive ages.
Poppe K, Velkeniers B. Female infertility and the thyroid. Best Pract Res Clin Endocrinol Metab [Internet]. 2004;18(2):153–65. Available from: https://www.sciencedirect.com/science/article/pii/S1521690X04000144
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 The role of thyroid function in male infertility

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9
 Causes of Infertility in Women

Endocrine, Lifestyle and Other

causes Ovulatory Disorders
19%
25%

Hyperprolactinaemia
7%

Endometriosis
15%
Tubal Abnormalities
22%

Pelvic Adhesions
12%

Unuane D, Velkeniers
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Impact of thyroid
— do disease on fertility and assisted conception. Best Pract Res Clin Endocrinol Metab [Internet]. 2020;34(4):101378. Available from:
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 Prevalence Data for Hypothyroidism in Infertility

● In women of reproductive age group, the prevalence of hypothyroidism is

2%–4%.
● The prevalence of hypothyroidism in infertile women is 27%.
● Among them, 25% have subclinical hypothyroidism and 2.33% overt
hypothyroidism.
● Prevalence of hyperprolactinemia in infertile women is 24.67%. The
association of hyperprolactinemia with hypothyroidism is 23%.

Koyyada A, Orsu P. Role of hypothyroidism and associated pathways in pregnancy and infertility: Clinical insights. Tzu Chi Med J [Internet]. 2020 [cited 2023 Apr 14];32(4):312–7. Available from: http://dx.doi.org/10.4103/tcmj.tcmj_255_19,Unuane D,
Velkeniers B. Impact of thyroid disease on fertility and assisted conception. Best Pract Res Clin Endocrinol Metab [Internet]. 2020;34(4):101378. Available from: https://www.sciencedirect.com/science/article/pii/S1521690X20300051,Pushpagiri N, Gracelyn L,
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Nagalingam S. Prevalence of subclinical and overt hypothyroidism in infertile women. Int J Reprod Contracept Obstet Gynecol [Internet]. 2015 [cited 2023 Apr 17];4(6):1733–8. Available from: https://www.ijrcog.org/index.php/ijrcog/article/view/2294
 Hypothyroidism and Infertility

• Hypothyroidism is the most common thyroid disorder especially in

females.
• It has a significant effect on fertility causing anovulatory cycles, luteal
phase defect, hyperprolactinemia and sex hormone imbalances.
• Studies show that hypothyroid women have a decreased fertility rate
than normal women, and even if they conceive, the children born may
have impairment of IQ levels, learning abilities, and
neuropsychological issues.

Koyyada A, Orsu P. Role of hypothyroidism and associated pathways in pregnancy and infertility: Clinical insights. Tzu Chi Med J [Internet]. 2020 [cited 2023 Apr 14];32(4):312–7. Available from: http://dx.doi.org/10.4103/tcmj.tcmj_255_19,Pushpagiri N,
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Gracelyn L, Nagalingam S. Prevalence of subclinical and overt hypothyroidism in infertile women. Int J Reprod Contracept Obstet Gynecol [Internet]. 2015 [cited 2023 Apr 17];4(6):1733–8. Available from:
https://www.ijrcog.org/index.php/ijrcog/article/view/2294,
 Hypothyroidism and Infertility

• Hypothalamic–pituitary–ovarian axis  physiologically related to

Hypothalamic-Pituitary-Thyroid axis

• Thyroid hormones binding to their receptor in ovary and subsequently

stimulate follicles.

• Hypothyroidism results in a number of hormonal changes which in turn cause

ovulatory disturbances, insufficiency of corpus luteum

Koyyada A, Orsu P. Role of hypothyroidism and associated pathways in pregnancy and infertility: Clinical insights. Tzu Chi Med J [Internet]. 2020 [cited 2023 Apr
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14];32(4):312–7. and confidential
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 Clinical Consequences of Hypothyroidism on Female Reproductive
Hormones
Reproductive Hormone Impact due to
Hypothyroidism
GnRH Increases
FSH Inconsistent
LH Inconsistent
Prolactin Increases
Oxytocin Decreases
Progesterone Decreases
Ren B, Zhu Y. A new perspective on thyroid hormones: Crosstalk with reproductive hormones in females. Int J Mol Sci [Internet]. 2022 [cited 2023 Apr 17];23(5):2708. Available from:
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Higher TSH levels within the normal range are associated with unexplained infertility

Background: Unexplained infertility (UI), defined as the inability to conceive after 12 months of unprotected
intercourse with no diagnosed cause, affects 10% to 30% of infertile couples.

Objective: To compare TSH and prolactin levels in women with UI and women with a
normal fertility evaluation except for an azoospermic or severely oligospermic male
partner.
Design, Setting, and Participants: Cross-sectional study including women evaluated at a large
academic health system with normal TSH (levels within the normal range of the assay and < 5
mIU/L) and normal prolactin levels (< 20 ng/mL) and either UI (n = 187) or no other cause of
infertility other than an azoospermic or severely oligospermic partner (n = 52).
Results: Women with UI had significantly higher TSH levels than controls [UI: TSH 1.95 mIU/L,
interquartile range: (1.54, 2.61); P = 0.003]. This finding remained significant after we controlled for
age, body mass index, and smoking status. Nearly twice as many women with UI (26.9%) had a TSH >
2.5 mIU/L compared with controls (13.5%; P < 0.05). Prolactin levels did not differ between the
groups.

Conclusion: Women with UI have higher TSH levels compared with a control
population.

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Jokar TO, Lindsay T, Fourman LT, et al. Higher TSH levels within the normal range are associated with unexplained infertility. J Clin Endocrinol Metab 2018;103:632e9.
Subclinical Hypothyroidism and Infertility

● Subclinical hypothyroidism (SCH), a mild form of hypothyroidism

defined as elevated TSH with normal free thyroxine levels, is a common
diagnosis among women of reproductive age.
● In some studies, it has been associated with infertility, an increased risk of
adverse pregnancy and neonatal outcomes, and possibly with an increased
risk of neurocognitive deficits in offspring.

Maraka S, Singh Ospina NM, Mastorakos G, O’Keeffe DT. Subclinical hypothyroidism in women planning conception and during pregnancy: Who should be treated and how? J
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2018;2(6):533–46. distribute
from: http://dx.doi.org/10.1210/js.2018-00090
 Subclinical Hypothyroidism and Infertility

Using TRH tests A cross-sectional study

conducted in 2018, also
to define SCH showed higher normal
Bohnet et al. TSH levels in women with
unexplained infertility
linked 11% of compared to fertile
infertility to controls.

subtle
In a large retrospective
A meta-analysis of 3
RCT's showed some
underfunctionin
cross-sectional study in
beneficial effect of
11,254 women in
gDenmark,
of theimpaired
thyroid. levothyroxine treatment
fertility was associated on pregnancy after ART
with subclinical in women with subclinical
hypothyroidism defined as hypothyroidism.
TSH >3.7 mIU/L.

Unuane D, Velkeniers B. Impact of thyroid disease on fertility and assisted conception. Best Pract Res Clin Endocrinol Metab [Internet]. 2020;34(4):101378. Available from:
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Thyroid Autoimmunity and Female
Infertility

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 Thyroid Autoimmunity and Female infertility

● TAI is the most frequent autoimmune disorder in women of childbearing age

and increases the risk of thyroid dysfunction.
● A meta-analysis pooling 4 studies showed that the presence of
thyroid antibodies in euthyroid patients is associated with unexplained
subfertility
● TAI has been linked to adverse pregnancy outcomes with an increased risk of
miscarriage and preterm delivery in spontaneous pregnancy as well as in
pregnancy after ART.
● The presence of thyroid antibodies may have an unfavourable effect on oocyte
and embryo quality.

Unuane D, Velkeniers B. Impact of thyroid disease on fertility and assisted conception. Best Pract Res Clin Endocrinol Metab [Internet]. 2020;34(4):101378. Available from:
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 Thyroid Autoimmunity and Female infertility

● Monteleone et al. also found a significantly lower oocyte fertilization and

percentage of grade A embryos when comparing infertile women undergoing IVF
with thyroid autoimmunity to negative controls.
● Women with TAI are at increased risk of developing (sub) clinical hypothyroidism
during spontaneous pregnancy.
● In the case of assisted reproductive technology (ART) and
ovarian hyperstimulation, it has been reported that TSH levels increase
significantly above 2.5 mIU/L before pregnancy and even more so in the presence
of TAI.
● Since thyroid hormones play an essential role in oocyte maturation and
implantation, the decline in thyroid function induced by the stimulation protocol
in women with TAI may negatively influence pregnancy rate in ART.

Unuane D, Velkeniers B. Impact of thyroid disease on fertility and assisted conception. Best Pract Res Clin Endocrinol Metab [Internet]. 2020;34(4):101378. Available from:
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 Recommendations for Screening
Body Recommendation

European Thyroid association (ETA 2021) All women seeking medical advice for
subfertility should be screened for serum TSH
and TPOAb.

SOGC committee opinion (2020) Suggest that clinicians who check

thyroidstimulating hormone (TSH) in all infertile
women with minor elevations of TSH (4–10
mIU/L) should have repeat test at least 4 weeks
later because minor elevations in TSH will
normalize.

ATA 2017 Recommend screening for all infertile women

ASRM 2015 Not Recommended

Nellepalli S, Reddy R, Vembu R. Thyroid dysfunction and infertility [Internet]. Available from: https://www.thejgog.com/wp-content/uploads/2021/07/06_JGOG_Thyroid_article_final.pdf
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 Recommendations for Antibody testing

Body Recommendation

American Association of clinical Antibody testing is indicated in women

endocrinologists with (a) TSH >2.5 mIU/L on repeated
testing, (b) history of recurrent
miscarriage, and (c) serum TSH between
2.5 and 4 mIU/L.

ESHRE 2015 Recommends screening in women with

diminished ovarian reserve and premature
ovarian insufficiency.

ETA (2021) TPO-ab testing for all women seeking

infertility evaluation.

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Nellepalli S, Reddy R, Vembu R. Thyroid dysfunction and infertility [Internet]. Available from: https://www.thejgog.com/wp-content/uploads/2021/07/06_JGOG_Thyroid_article_final.pdf
Management of Hypothyroidism in
Infertility

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April 23, 2024 23
Approach to Hypothyroidism in Infertility
• In the case of overt thyroid dysfunction the appropriate therapy should promptly be
initiated.
• SCH is best treated when TSH values exceed the normal upper value defined by the
population specific non pregnant values, or in the absence of these reference ranges by
a fixed cut-off of 4 mIU/L.
• Given the uncertainties in literature concerning the harm/benefit ratio in patients with
TSH cutoff levels between 2.5 and 4.0 mIU/, intervention in these cases should be
restricted and discussed with the patients in regard to the current best available
evidence.

Proprietary
Unuane and confidential
D, Velkeniers —thyroid
B. Impact of do notdisease
distribute
on fertility and assisted conception. Best Pract Res Clin Endocrinol Metab [Internet]. 2020;34(4):101378
April 23, 2024 24
Approach to Hypothyroidism in Infertility
Women of
Infertile
Couples

TSH,
Thyroid
Antibodie
s
TSH 0.3-4) TSH <0.3
TSH >4.0 mIU/L mIU/L
mIU/L

Start LT4 6 Thy abs

Thy abs fT4 and fT3
weeks Prior to negativ fT4 and fT3
Positive
OH/ART e Normal increased
Follow up Follow up
thyroid Check
Thyroid TSH after
function Function every 4 Treat with
every 4 OH ATD or
weeks
weeks surgery

If TSH > 4.0 mIU/L

Start LT4 + follow
up every 4 weeks
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April 23, 2024 25
Indications for LT4 Replacement in Infertility
The indications to start LT4 include:

(a) overt hypothyroidism

(b) serum TSH levels >4.0 mIU/L irrespective of TAI, and

(c) serum TSH level between 2.5 and 4.0 m IU/L with TPO-ab positive.

Nellepalli S, Reddy R, Vembu R.—

Thyroid dysfunction
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https://www.thejgog.com/wp-content/uploads/2021/07/06_JGOG_Thyroid_article_final.pdf
April 23, 2024 26
Recommendations for LT4 Replacement in Infertility
• LT4 treatment is not recommended in euthyroid women with TAI undergoing
IVF/ICSI and serum TSH level between 2.5 and 4.0 m IU/L with TPO-ab negative.

• This is supported by the TABLET trial which did not show any beneficial effect of LT4
on live birth rate in these women.
• LT4 is started in the dose of 25–50 mcg/day for 4 weeks based on clinical and
biochemical assessment and serum TSH levels are monitored. The dose is increased
every 4 weeks by 25 mcg based on serum TSH levels

Nellepalli S, Reddy R, Vembu R.—

Thyroid dysfunction
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April 23, 2024 27
 Preconception Treatment with Levothyroxine

● Overt hypothyroidism must be treated before conception and the TSH levels must
be maintained <2.5 mIU/L.
● At present, there is insufficient evidence to initiate levothyroxine treatment at
preconception TSH levels between 2.5 and 4.0 mIU/L, in particular in the case of
ART.esp if anti Tpo are negative.
● Because the reference range of TSH changes when a woman becomes pregnant,
some advocate using pregnancy thresholds for the treatment of women attempting
conception in order to minimize the potential risks associated with SCH in
pregnancy however this strategy is controversial.

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Practice Committee of the American Society for Reproductive Medicine. Subclinical hypothyroidism in the infertile female population: a guideline. Fertil Steril [Internet]. 2015;104(3):545–53.
Available from: https://www.sciencedirect.com/science/article/pii/S0015028215003799
Impact of LT4 on IVF Outcomes

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 Effect Of Levothyroxine Treatment On In Vitro Fertilization And Pregnancy
Outcome In Infertile Women With Subclinical Hypothyroidism Undergoing In
Vitro Fertilization/Intracytoplasmic Sperm Injection

Objective Method Results

There were no differences in patient characteristics
A total of 64 infertile between the two groups. The number of grade I or II
To investigate whether patients with subclinical embryos was significantly higher in the LT4 treatment
levothyroxine (LT4) hypothyroidism, were group than in the control group. The miscarriage rate was
treatment has beneficial randomized into an LT4 significantly lower in the LT4 treatment group than in the
effects on IVF results and treatment group or control group. Embryo implantation rate and live birth
control group. For the LT4 rate were significantly higher in the LT4 treatment group.
pregnancy outcome in treatment group, 50 μg In the control group, both thyroid peroxidase antibody
infertile patients with LT4 was administered and thyroglobulin antibody levels were significantly higher
in the miscarried subgroup than in the delivered
subclinical from the first day of
subgroup.
hypothyroidism controlled ovarian
stimulation for IVF/ICSI.
undergoing
IVF/intracytoplasmic
sperm injection (ICSI).

LT4 treatment can improve embryo quality Conclusion

and pregnancy outcome in subclinical hypothyroid women
undergoing IVF/ICSI.

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Kim C-H, Ahn J-W, Kang SP, Kim S-H, Chae H-D, Kang B-M. Effect of levothyroxine treatment on in vitro fertilization and pregnancy outcome in infertile women with subclinical hypothyroidism undergoing in vitro
fertilization/intracytoplasmic sperm injection. Fertil Steril [Internet]. 2011;95(5):1650–4. Available from: https://www.sciencedirect.com/science/article/pii/S0015028210029286
 In vitro fertilization Outcomes in Treated Hypothyroidism

Method: Patients who underwent IVF–intracytoplasmic sperm injection (ICSI) over a 3-year
period were reviewed. Cases were deemed eligible if they were diagnosed with clinical or
subclinical hypothyroidism and were receiving levothyroxine. Controls were two
subsequently age-matched euthyroid women for every case. Both cases and controls were
selected only if serum thyrotropin was ≤2.5 mIU/L.

Conclusion: IVF-ICSI outcome was not significantly hampered in women with adequately
treated hypothyroidism. In conclusion, adequate levothyroxine treatment maintaining
thyrotropin serum levels below 2.5 mIU/L may overcome the detrimental effects of
hypothyroidism.

Busnelli A, Somigliana E, Benaglia L, Leonardi M, Ragni G, Fedele L. In vitro fertilization outcomes in treated hypothyroidism. Thyroid [Internet]. 2013;23(10):1319–25.
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GUIDELINES

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April 23, 2024 32
ATA-2017 Guidelines in Pregnancy & Thyroid
Disorders (Recommendations)
 All pregnant women should ingest approximately 250 micro g of Iodine
daily except who are being treated for hyperthyroidism or who are taking
LT4 & in preparation for the surgical treatment of GD.

 Euthyroid pregnant women who are TPOAb or TgAb positive should have
measurement of serum TSH concentration performed at time of
pregnancy confirmation and every 4 weeks through mid pregnancy.

 Intravenous immunoglobulin treatment of euthyroid women with a

history of recurrent pregnancy loss is not recommended.

 Evaluation of serum TSH concentration is recommended for all women

seeking care for infertility.
Thyroid. 2017 Mar;27(3):315-389.
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ATA-2017 Guidelines in Pregnancy & Thyroid
Disorders (Recommendations)
 LT4 treatment is recommended for infertile women with overt hypothyroidism who desire
pregnancy.

 Subclinically hypothyroid women undergoing IVF or intracytoplasmic sperm injection (ICSI)

should be treated with LT4. The goal of treatment is to achieve a TSH concentration.

 Glucocorticoid therapy is not recommended for thyroid autoantibody–positive euthyroid women

undergoing ART.

 Isolated hypothyroxinemia should not be routinely treated in pregnancy.

 The recommended treatment of maternal hypothyroidism is administration of oral LT4. Other

thyroid preparations such as T3 or desiccated thyroid should not be used in pregnancy.

Thyroid. 2017 Mar;27(3):315-389.

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April 23, 2024 34
Reference Limits of TSH and Thyroid Hormones
Dosage
Parameter 2014 European thyroid association guidelines 2017 American thyroid
association guidelines

TSH - Trimester-specific reference ranges should be - Reference range for each trimester
established in each laboratory. adjusted for the population
Or
- If not available, the following reference range are - TSH < 4 mU/mL
recommended: first trimester upper limits
2.5 mU/L; second trimester upper limits
3.0 mU/L; third trimester upper limits 3.5 mU/L
fT4 -T4 and fT4 assays are both suitable for thyroid function -T4 analysis is suitable instead of
T4 testing in pregnancy fT4

fT3 - -T3 analysis could be helpful in the

T3 diagnosis and management of
hyperthyroidism, in the presence of
suppressed TSH

Vander Borght M, Wyns C. Fertility and infertility: Definition and epidemiology. Clinical Biochemistry 2018;62:2–10. https://doi.org/10.1016/j.clinbiochem.2018.03.012.
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Follow up of Clinical Cases

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Case 1 Follow Up
After 6 months of follow‐up, keeping TSH below 2.5 μIU/mL (optimal for pregnancy),
she conceived again. Miscarriage at 14th Gestational week.

Two months later, she conceived.

Managed with aspirin, Levothyroxine, B12 Folate with cobalamin. Delivered a healthy
baby.

Thereafter, TSH = 1.23 μIU/mL, FT4 = 1.15 ng/dL, FT3 = 2.53 pg/mL, and
TPOAb = 482 IU/mL at 6 months after delivery.

Allam MM, El‐Zawawy HT, Barakat SS, Ahmed SM, Saleh RNM. A hidden cause of infertility in hypothyroid patients. Clinical Case Reports 2020;8:374–8. https://doi.org/10.1002/ccr3.2654.
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April 23, 2024 37
Case 2 Follow up
She conceived after 2 months of maintaining TSH below 2.5 μIU/mL and TPOAb level
decreased to 357 IU/mL.

During pregnancy, maintained on low‐dose aspirin, Levothyroxine 150 mcg, enoxaparin

40 mg, B12 Folate 500 mg with cobalamin 1000 mg.

Unfortunately, the patient stopped the treatment on her own after 12 weeks, delivered a
baby with multiple congenital anomalies and baby died 3 weeks later.

She conceived six months later; compliance was attained after explanation of the benefit
of Folate and Levothyroxine.

Eventually, she delivered a healthy female baby.

[1] Allam MM, El‐Zawawy HT, Barakat SS, Ahmed SM, Saleh RNM. A hidden cause of infertility in hypothyroid patients. Clinical Case Reports 2020;8:374–8. https://doi.org/10.1002/ccr3.2654.
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April 23, 2024 38
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