Risk of endometrial cancer in women treated with ovary‐stimulating drugs for subfertility

Alkistis Skalkidou; Theodoros N Sergentanis; Spyros P Gialamas; Marios K Georgakis; Theodora Psaltopoulou; Marialena Trivella; Charalampos S Siristatidis; Evangelos Evangelou; Eleni Petridou

doi:10.1002/14651858.CD010931.pub2

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Figure 1

PRISMA Flow Diagram

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 4

Forest plot of comparison: 2 Exposure to any drug; comparison group: subfertile; any, outcome: 2.1 Endometrial cancer; subgroup by effect estimate.

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Figure 5

Forest plot of comparison: 6 Exposure to any drug; comparison group: general population; any, outcome: 6.1 Endometrial cancer; subgroup by effect estimate.

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Figure 6

Funnel plot of comparison: 6 Exposure to any drug; comparison group: general population; any, outcome: 6.1 Endometrial cancer; subgroup by effect estimate.

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Analysis 1.1

Comparison 1 Exposure to any drug; comparison group: subfertile; any, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 2.1

Comparison 2 Exposure to any drug; comparison group: subfertile; parous women, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 3.1

Comparison 3 Exposure to any drug; comparison group: subfertile; nulliparous women, Outcome 1 Endometrial cancer.

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Analysis 4.1

Comparison 4 Exposure to any drug; comparison group: subfertile; low number of cycles, Outcome 1 Endometrial cancer.

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Analysis 5.1

Comparison 5 Exposure to any drug; comparison group: subfertile; medium number of cycles, Outcome 1 Endometrial cancer.

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Analysis 6.1

Comparison 6 Exposure to any drug; comparison group: general population; any, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 7.1

Comparison 7 Exposure to any drug; comparison group: general population; low number of cycles, Outcome 1 Endometrial cancer.

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Analysis 8.1

Comparison 8 Exposure to any drug; comparison group: general population; medium number of cycles, Outcome 1 Endometrial cancer.

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Analysis 9.1

Comparison 9 Exposure to any drug; comparison group: general population; 0‐3 number of oocytes retrieved, Outcome 1 Endometrial cancer.

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Analysis 10.1

Comparison 10 Exposure to any drug; comparison group: general population; >10 number of oocytes retrieved, Outcome 1 Endometrial cancer.

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Analysis 11.1

Comparison 11 Exposure to clomiphene; comparison group: subfertile: any, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 12.1

Comparison 12 Exposure to clomiphene; comparison group: subfertile; low dosage, Outcome 1 Endometrial cancer.

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Analysis 13.1

Comparison 13 Exposure to clomiphene; comparison group: subfertile; medium dosage, Outcome 1 Endometrial cancer.

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Analysis 14.1

Comparison 14 Exposure to clomiphene; comparison group: subfertile; high dosage, Outcome 1 Endometrial cancer.

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Analysis 15.1

Comparison 15 Exposure to clomiphene; comparison group: subfertile; medium number of cycles, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 16.1

Comparison 16 Exposure to clomiphene; comparison group: subfertile; high number of cycles, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 17.1

Comparison 17 Exposure to clomiphene; comparison group: subfertile: parous women, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 18.1

Comparison 18 Exposure to clomiphene; comparison group: subfertile; nulliparous women, Outcome 1 Endometrial cancer.

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Analysis 19.1

Comparison 19 Exposure to clomiphene; comparison group: general population; any, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 20.1

Comparison 20 Exposure to clomiphene; comparison group: general population; low dosage, Outcome 1 Endometrial cancer.

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Analysis 21.1

Comparison 21 Exposure to clomiphene; comparison group: general population; high dosage, Outcome 1 Endometrial cancer.

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Analysis 22.1

Comparison 22 Exposure to clomiphene; comparison group: general population; low number of cycles, Outcome 1 Endometrial cancer.

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Analysis 23.1

Comparison 23 Exposure to clomiphene; comparison group: general population; high number of cycles, Outcome 1 Endometrial cancer.

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Analysis 24.1

Comparison 24 Exposure to gonadotropins; comparison group: subfertile; any, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 25.1

Comparison 25 Exposure to gonadotropins; comparison group: subfertile; medium number of cycles, Outcome 1 Endometrial cancer.

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Analysis 26.1

Comparison 26 Exposure to gonadotropins; comparison group: subfertile; high number of cycles, Outcome 1 Endometrial cancer.

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Analysis 27.1

Comparison 27 Exposure to gonadotropins; comparison group: general population; any, Outcome 1 Endometrial cancer.

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Analysis 28.1

Comparison 28 Exposure to clomiphene + gonadotropins; comparison group: subfertile; any, Outcome 1 Endometrial cancer.

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Analysis 29.1

Comparison 29 Exposure to clomiphene + gonadotropins; comparison group: general population; any, Outcome 1 Endometrial cancer.

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Analysis 30.1

Comparison 30 Exposure to GnRH; comparison group: subfertile; any, Outcome 1 Endometrial cancer.

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Analysis 31.1

Comparison 31 Exposure to GnRH; comparison group: subfertile; parous women, Outcome 1 Endometrial cancer.

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Analysis 32.1

Comparison 32 Exposure to GnRH; comparison group: subfertile; nulliparous women, Outcome 1 Endometrial cancer.

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Analysis 33.1

Comparison 33 Exposure to any drug; comparison group: subfertile; any; follow‐up >10 years, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 34.1

Comparison 34 Exposure to any drug; comparison group: general population; any; follow‐up>10 years, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 35.1

Comparison 35 Exposure to clomiphene; comparison group: subfertile; any; follow‐up>10 years, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 36.1

Comparison 36 Exposure to clomiphene; comparison group: general population; any; follow‐up>10 years, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 37.1

Comparison 37 Exposure to gonadotropins; comparison group: subfertile; any; follow‐up>10 years, Outcome 1 Endometrial cancer; subgroup by effect estimate.

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Analysis 38.1

Comparison 38 Exposure to clomiphene + gonadotropins; comparison group: general population; any; follow‐up>10 years, Outcome 1 Endometrial cancer.

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Summary of findings for the main comparison. Exposure to any ovary‐stimulating drugs for subfertility compared to untreated subfertile women and endometrial cancer risk

Patient or population: Women treated with ovary‐stimulating drugs for subfertility Intervention: Exposure to any ovary‐stimulating drug for subfertility Comparison: Untreated subfertile women
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with no treatment	Risk with exposure to any ovary‐stimulating drug for subfertility
Endometrial cancer	Study population		RR 0.96 (0.67 to 1.37)	156,774 (6 observational studies)	⊕⊝⊝⊝ Very low ^1,2,3
	111 per 100,000	109 per 100,000 (74 to 163)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Initial level of evidence was 'low' because of the study design (observational studies). ² Downgraded because of high risk of bias. ³Optimal information size (OIS) criterion not met (OIS = 499,938); however, the sample size was large.

Summary of findings for the main comparison. Exposure to any ovary‐stimulating drugs for subfertility compared to untreated subfertile women and endometrial cancer risk

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Patient or population: Women treated with ovary‐stimulating drugs for subfertility Intervention: Exposure to gonadotropins for subfertility Comparison: Untreated subfertile women
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with no treatment	Risk with exposure to gonadotropins for subfertility
Endometrial cancer	Study population		RR 1.55 (1.03 to 2.34)	17,769 (4 observational studies)	⊕⊝⊝⊝ Very low ^1,2,3
	1291 per 100,000	1987 per 100,000 (1329 to 2970)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Initial level of evidence was 'low' because of the study design (observational studies). ² Downgraded because of risk of bias in most studies and imprecise estimates in one study. ³ Optimal information size (OIS) not met.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Endometrial cancer; subgroup by effect estimate Show forest plot	6	156774	Risk Ratio (Random, 95% CI)	0.96 [0.67, 1.37]

1.1 RR	2	12548	Risk Ratio (Random, 95% CI)	1.31 [0.61, 2.81]
1.2 IRR	2	32131	Risk Ratio (Random, 95% CI)	0.86 [0.46, 1.63]
1.3 HR	2	112095	Risk Ratio (Random, 95% CI)	0.90 [0.52, 1.54]

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