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Study reference

(first author, year                    of publication)

Was           there                    a representative and well-defined sample of patients at a similar point in the course of the disease?

(yes/no/unclear)

Was follow-up sufficiently long and complete?

(yes/no/unclear)

Was the outcome of                  interest defined                               and adequately measured?

(yes/no/unclear)

Was                            the

prognostic factor of                  interest defined                                and adequately measured?

(yes/no/unclear)

Was           loss                    to

follow-up                                           / incomplete outcome                          data

described                           and acceptable?

(yes/no/unclear)

Was                       there statistical adjustment for all important prognostic factors?

(yes/no/unclear)

Level of evidence

Casadei 2013

Yes

Yes

Yes

Yes

Unclear

Yes

A2

Haadsma 2008

Yes

Yes

Yes

Yes

Yes

Yes

A2

Van

Yes

Yes

Yes

Yes

Yes

Yes

B

Montfrans 2000

Van              Rooij 2006

Yes

Yes

Yes

Yes

Yes

No

B

Van              Rooij 2004

Yes

Yes

Yes

Yes

Unclear

Yes

A2

Van                  der Steeg 2007

Yes

Yes

Yes

Yes

Yes

Yes

A2

funding: not reported

-                               androgen secreting tumours

-                                  cushing

syndrome

-  male infertility

-  tubal pathologies

-  anovulation

-

hyperprolactinaem ia

-                  hypothalamic amenorrhoa

-       previous ovarian surgery

-  ovarian tumours

-                          anatomical abnormalities of uterine cavity

-              intraperitoneal adhesions

-                endometriosis and other pelvic

complete outcome data available? N (%):

Not described

Reasons for incomplet e outcome data described

?

Not described

with FSH;

but                    no

marker has a predictive value of spontaneou s onset of pregnancy

pathologies

-                                      thyroid

dysfunction                                  and other endocrinological disorders

-                               recurrent pregnancy loss

-                     autoimmune disease

N:

83        women            with unexplained infertility        out            of

425                infertility couples

Mean age ± SD:

35.9 ± 5.4 years

Sex: % M / 100%

F:

(subfertile

male/female

couples)

Other                important

characteristics

(confounders and

effect modifiers):

-duration                                 of

infertility                       (years)

all women: 2.8 ±

2.4;

-AMH (pmol/l) all

women: 12.54 ±

10.49;

-AFC all women:

6.2 ± 4.2 follicles

(range 1-15);

-primary infertility

(N): 54

1st

Type                      of

Inclusion criteria:

Describe

Endpoint

Outcome measures and effect size (include 95%CI and p- value if available):

-      Time to spontaneous pregnancy resulting in live birth

Hunault model

(see table III)

Author’s

author,

year               of publicati on

Haadsma 2008

study:

Prospective cohort study

Setting:

Outpatients

,                   two

hospitals in Groningen

-subfertility for at least 12 months

-regular ovulatory cycle                              with

midluteal progesterone ≥ 30 mmol/l and mean cycle between 21-

42 days

prognostic factor(s) and method of measureme nt:

Peripheral blood                 was

drawn                     to measure

of follow- up:

Spontaneo us conceptio n within 1 year resulting in                live

birth

conclusion:

When added                             to the Hunault model, only basal                  FSH

(and                AFC) significantly improved the

-        at      least         one

basal levels

prediction

patent        tube                      at

of FSH and

of

Country:

hysterosalpingogra

inhibin B. 9.

For              how

spontaneou

The Netherlands

Source                      of funding:

phy                         and/or laparoscopy

-          semen analysis with a total count

> 1*106

-               no        sexual

One              week

after                  the

first                visit, blood samples were drawn again                           to

many participan ts were no complete outcome data available?

s pregnancy (P-values of 0.05)

Not

disorder leading to

measure

N (%):

described

coitus frequency or less than one a month

Exclusion criteria:

stimulated FSH                  and inhibin                            B level.s

Eligible patients: N=732

Included

Not described

N:

474         sub                fertile ovulatory couples

Mean age ± SD:

32.5 median; 26.6-

38.8                10th-90th percentiles

Sex: % 50 M / % 50 F:

Subfertile couples

Other                important characteristics (confounders and effect modifiers)

-Duration                                of subfertility (months):                                                    26.5

patients: N=569

Assessed patients: N=474

(flowchart

)

End                  of follow-up N:26

Loss                  of follow-up N:9

End of relationshi p N:7

End                  of

desire                  to have children N:7

Spontaneo us

(16.8 – 50.4 10th-

90th percentiles)

- Primary fertility (N): 324 (68.4%)

Sperm                  motility (TMC, *106): 34.5

(4.0 – 175.6 10th-

90th percentiles)

pregnancy with unknown outcome N:3

Reasons for incomplet e outcome data described

?

See above, no other informatio n given

1st author,

year                of publicati on

van Montfran

Type                    of study: nested

case-control

Setting:

outpatients

Inclusion criteria:

1)         women with subfertility with basal FSH >10 IU/L and age-matched subfertiel controls

2)  age ≤40 years

3)                             average

Describe prognostic factor(s) and method of measureme nt:

Endpoint of follow- up:            3-7 years

For             how many participan

Outcome measures and effect size (include 95%CI and p- value if available):

Number of spontaneous pregnancies: Case: 16/20

Control: 17/23

Author’s conclusion:

The           results of this study suggest that screening for elevated basal                   FSH concentrati

s 2000

Country:

Source                  of funding:

Not reported

menstrual cycle length <42 days

4)        subfertility ≥12 months

5)                            ovulatory menstrual cycles

Exclusion criteria:

1)                 history               of unilateral ovariectomy

2)                 history of chemotherapy or irradiation

N: 50 women with subfertility with basal FSH >10 IU/L and (20 allocated to                     expectant management)

50 age-matched subfertiel controls

FSH

measured on cycle day

3 with an immunomet ric assay

ts were no complete outcome data available? N (%): not reported

Reasons for incomplet e outcome data described

?

not reported

Odds Ratio: 0.78 (95% CI: 0.35 – 1.7)

ons is of no additional value in a general subfertility population with ovulatory menstrual cycles.

(23        allocated              to expectant management)

Mean age ± SD

Case: 35 ± 4.3

Control: 34 ± 4.3

Sex: 100% F

Other               important characteristics (confounders and effect modifiers):

Primary subfertility:

1st author,

year             of

Type                    of study:

Retrospecti

Inclusion criteria:

-18-46 year

-two                     ovaries

Describe prognostic factor(s) and method

Endpoint of follow- up:

Outcome measures and effect size (include 95%CI and p- value if available):

1Ongoing

pregnancy is defined as a viable

publicati

ve           follow-

present

of

Ongoing

Treatment independent pregnancy:

pregnancy

on

van Rooij 2004

up study

Setting:

outpatients,

Tertiary fertility center

Country:

The Netherlands

Source                     of funding:

-regular menstrual cycle between 21

and 35 days

-trying to become pregnant for at least 12 months.

Exclusion criteria

Not described.

measureme nt:

-FSH values measured between July                1995

and                  July

1999               were obtained from        the clinical chemistry laboratory

pregnancy

1

For             how many participan ts were no complete outcome data available? N (%):

of at least 11 weeks of gestational age.

Authors conclusion:

The contribution of       FSH     in the          initial evaluation

N=

database.

Not

of                 sub

-122 patients with normal FSH levels

<10.0 IU/L

-126 patients with

FSH 10.0-15.0 IU/l

-        53 with SH >

15.0 IU/L

Median age (10th-

Serum concentrati ons of FSH were initially measured by                  the

Ezymun-FSH test.               After

1996,                  FSH

was

reported.

Reasons for incomplet e outcome data described

?

-No

fertile couples         is restricted to counselling patients on the probability of               having lower chances        of conceiving.

90th percentile):

measured in

ongoing

- normal FSH levels

<10.0       IU/L:                  33.4

(27.9-38.1)

-       FSH      10.0-15.0

IU/l:       34.6                (29.5-

40.9)

- FSH > 15.0 IU/L: 36.8 (29.7-41.1)

Other              important characteristics (confounders and effect modifiers):

(Median (10th-90th percentile)

-Duration                               of infertility (months)

- normal FSH levels

<10.0 IU/L: 28 (14-

66)

-       FSH      10.0-15.0

IU/l: 25 (12-60)

plasma using                   the automatic FSH

immunomet ric                  FSH

assay.

pregnancy before start                  of treatment.

-

Proceedin g                  to

treatment

-

Inseminati on at first line of treatment

37

2Overall,

treatment- dependent ongoing pregnancy, time                               to ongoing pregnancy were                 also outcome measures.

- FSH > 15.0 IU/L: 25(13-73)

Primary                        fertility disorder:

--         normal            FSH levels <10.0 IU/L:

80(66)

-       FSH      10.0-15.0

IU/l:88 (70)

- FSH > 15.0 IU/L: 29 (55)

1st author,

year              of publicati on

van Rooij 2006

Type of study:

prospective observation al study

Setting:

outpatients

Country:

Inclusion criteria:

1)                      patients diagnosed                             with unexplained infertility or a mild male factor:

-regular cycle 25 – 35 days

-biphasic                            body temperature chart

- tubal pathology

Describe prognostic factor(s) and method of measureme nt:

FSH

measured on 2,3 or 4th

Endpoint of follow- up:

11.4

months

(10th – 90th percentile: 2.2 – 35.1

months)

For             how

Outcome measures and effect size (include 95%CI and p- value if available):

Advice: expectant management:

Spontaneous ongoing pregnancy: FSH <10 IU/L: 23 / 43 (56%)

FSH: 10.0 – 14.9 IU / L: 0 / 3 (0%)

Author’s conclusion:

Ovarian reserve tests, other than chronologic al age, seem of          limited value                 in predicting

Source                  of funding: not reported

excluded

-normal postcoital test

-normal semen analysis

-mild male factor: semen analysis did not meet standard for normality as defined by WHO or Kruger, but minimal                         total motile count of

>10        x     106               and absence                                of immunological factor

2) duration of infertility                           ≥12 months

Exclusion criteria:

1)  sexual disorders

2)                       endocrine

cycle day

Automated immunomet ric                  FSH

assay

many participan ts were no complete outcome data available? N (%): not reported

Reasons for incomplet e outcome data described

?

not reported

Advice: start treatment:

Spontaneous ongoing pregnancy: FSH <10 IU/L: 24 / 98 (24%)

FSH: 10.0 – 14.9 IU / L: 3 / 12 (25%)

FSH > 15 IU / L: 1 / 5 (20%)

(time        to) ongoing pregnancy in          patients with unexplained and                mild male infertility.

disorders

N: 222, 56 couples allocated                               tot expectant management

Mean age (10th – 90th percentile):

34 (37 – 39)

Sex: couples

Other                important characteristics (confounders and effect modifiers):

Duration                                 of infertility: 2.0 (1.3

– 5.0) YEARS

1st author,

year               of publicati on

Van            der Steeg 2007

Type                     of study:

Prospective cohort study

Setting:

outpatients

Multicenter

,

Country:

The Netherlands

Source                     of funding:

Inclusion criteria:

-Women without two-sided tubal pathology

-man with normal sperm parameters (total motile count

≥ 3*106)

Exclusion criteria:

No information was given.

N:

3519 consecutive couples

Mean age ± SD

-Femal age (yr; median, 5th-95th percentile)):

Describe prognostic factor(s) and method of measureme nt:

Basal FSH measureme nt on at

least                 one cycle d2-4 in each participatin g center.

Endpoint of follow- up:

Spontaneo us ongoing pregnancy

1

For              how many participan ts were no complete outcome data available? N (%):

249 (7.1%)

loss                  to follow-up

Reasons for incomplet

Outcome measures and effect size (include 95%CI and p- value if available):

Main outcome measure:

Spontaneous ongoing pregnancy

FSH (IU/liter) median: 6.6; 3.5-12 (5th-95th percentile)

-Hazard ratio (HR): 0.93/IU liter (95% CI 0.87-0.98)

-FSH level 8 IU/l or greater (HR 0.93/IU liter, 95 % CI 0.87- 0.99) is strong negative predictor of spontaneous pregnancy.

-Addition of FSH to prediction model changed the probability to conceive spontaneously from 30% or greater to less than 30 % in 97 of 3219 couples(3.0%).2

1:

spontaneou s         ongoing pregnancy is defined            as the presence of fetal cardiac activity            at transvaginal sonography at                    a

gestational age        of               at least 12 wk, resulting from treatment independen t conception.

2: The study aimed to estimate

32.6; 25-50

- Male age (yr; median 5th-95th percentile):

35.3 (27-45)

Sex: % 50 M / %50 F:

Consecutive couples

Other                important characteristics (confounders and effect modifiers):

-Femal age (yr; median, 5th-95th percentile)):

32.6; 25-50

-Cycle length (d; median, 5th-95th percentile):

e outcome data described

?

No spontaneo us pregnancy in 1 year (N:             2896;

82%):

-

Treatment

<12

months: N:1373 (39%)

-No conception in               12

months N: 1274

(36%)

-Lost                    to follow up :

the             clinical impact       if FSH were to be used in a prediction model               for pregnancy. For                      this purpose,    it was considered appropriate that couples with             a

probability of less than 30%        on                a spontaneou s pregnancy were counseled for treatment, whereas couples with                                a

probability of 30% or

28.1; 23-33

N:249;

7.1%)

less               were counseled for expectant managemen t.

Authors conclusion: In ovulatory women     a basal                        FSH level       of                 8 IU/L                             or

higher                             is associated with decreasing fecundity, independen t of femal age                  and cycle length. We do not recommend