Attachment 4b

Attachment 4.b. Summary of Published Prospective Pregnancy Studies with
Preconception Enrollment
Primary
Author
(Country)

Bonde
(Denmark)

Brown
(United
States)

Buck
(United
States)

Colombo
(Europe)

Length of
Follow-up
6 cycles or
until
pregnancy
occurred

Daily Diaries

9,671 (83%)
1,329/1,657
women; 820
completed (80%)
(59%) men

12 cycles, 2nd
miscarriage, or
N/A
delivery if
pregnancy
b
occurred
12 cycles, or
until 1st
postpartum
7 women missing
visit or
1+ weekly cards b
cessation of
breastfeeding
(if nursing)

Average of 8.6
cycles per
woman

Urine
Samples

80.6% included
BBT, 85.2%
included cervical
b
mucus score

N/A

N/A

84%
403 (84%)
completed
completed at least
at least one
b
one cycle
b
cycle

Hakim
(United
States)

At least 6
months or until
pregnancy
occurred
(mean = 7
cycles)

Near 100%

b

$100 for completion and
510 (44%) small gifts (e.g. pencils)
with newsletters

N/A

$50 for completion
through postpartum blood
& breast milk (97% of
20 (20%) women provided a
postpartum breast milk;
74% provided a second
b
sample upon weaning)

88/102
(86%)

N/A

6 cycles or
clinical
pregnancy

91 (38%)
completed the
entire protocol b

N/A

N/A

1304/1516 (86%)
completed b

6 months or
until
pregnancy
occurred

N/A

N/A

12 cycles or
until
pregnancy
occurred

France
(New
Zealand)

418/430
(97%)

N/A

Ellish
(United
States)

95%

Incentive(s) to
Participate

women:
288/317
(91%)
men:
350/376
(93%)

N/A

12 cycles or
until delivery

Eskenazi
(United
States)

Dropped
Semen
Out of the
Sample(s)
Study

N/A

de Mouzon
(France)

a

Blood
Sample(s)

N/A

N/A

N/A

N/A

a

N/A

N/A

90%

N/A

N/A

35 (8%)

$200 for specimens;
participants entered in a
b
lottery for $3,000

300 (25%)
84 of these
women re- None b
b
entered

687 (36%)

7%

a

$10 for every 2 months of
participation; lab results
were forwarded to
physicians b

$35 for each month of
participation; eligible for a
78 (16%) prize drawing for a trip to
Hawaii or other local
resort
Personal instruction
regarding fertility
148 (62%) awareness and the
Shettles theory of sex
selection b
$100 for completion of the
24 (16%) b study; feedback on
menstrual cycles

Primary
Author
(Country)

Sweeney
(United
States)

Sweeney
(United
States)

Vartiainen
(Finland)

Wang
(China)

Wilcox
(United
States)
Zinaman
(United
States)

Length of
Follow-up

12 months or
until
pregnancy
occurred

Daily Diaries

a

Dropped
Semen
Out of the
Sample(s)
Study

Urine
Samples

Blood
Sample(s)

Among
those
conceiving,
84%
provided
daily urines
(88%
weekly
urines)

N/A

N/A

N/A

N/A

a

None b

N/A

180 (94%) b

11 (6%)

None b

N/A

N/A

35 (4%)

$1 per 3 urine samples b

N/A

N/A

6 (3%)

$10/week for urine
collection

100%
(requirement
for
participation)

8 (4%)

$500 for completion of the
study

3 cycles or
until the end of
the 1st
81%
80%
trimester if
pregnancy
occurred
6 months or
88% 1st f/u;
until
N/A
59% 2nd f/u;
pregnancy
rd
b
39% 3 f/u
occurred
12 months or
545 (57%)
clinically
545 (57%)
completed
confirmed
completed at least
at least one
pregnancy
b
one cycle
cycle b
after stopping
contraception
6 months or
until
98% b
98%
pregnancy
occurred
12 months or
until
b
Over 90% b
Over 90%
pregnancy
occurred

a

Incentive(s) to
Participate

45 (55%) None b

NOTE: Cycles refer to menstrual cycles while months refer to calendar time. Adapted from Buck et
al., 2004.
a

= Information not available. b = Personal communication with author(s).
N/A = Information not applicable (i.e., did not estimate target population, enroll male partners
(couples), collect specimen(s), as appropriate)
f/u = Follow-up
Adapted from: Buck GM et al. Prospective Pregnancy Study Designs for Assessing Reproductive
Developmental Toxicants. Environmental Health Perspectives 2004;112:79-86