Trial Outcomes & Findings for Intrauterine Environment in Polycystic Ovary Syndrome (PCOS) Probands (NCT NCT00364949)

NCT ID: NCT00364949

Last Updated: 2013-04-10

Results Overview

The blood that were analyzed were taken from cord blood and not from the offspring.

• Recruitment status: COMPLETED
• Target enrollment: 70 participants
• Primary outcome timeframe: One time sampling from the cord blood
• Results posted on: 2013-04-10

Participant Flow

letters to participants from other studies and patients from Ob/Gyn at Northwestern

Exclusion based on personal/family history of diabetes or pre-existing medical condition

Participant milestones

Measure	Control Control	PCOS Polycystic Ovary Syndrome
Overall Study STARTED	31	39
Overall Study COMPLETED	31	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intrauterine Environment in Polycystic Ovary Syndrome (PCOS) Probands

Baseline characteristics by cohort

Measure	Control n=31 Participants Control	PCOS n=39 Participants Polycystic Ovary Syndrome	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	39 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	39 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	39 participants n=7 Participants	70 participants n=5 Participants
Pre-pregnancy BMI	25.1 kg/"m^2" STANDARD_DEVIATION 5.7 • n=5 Participants	30.8 kg/"m^2" STANDARD_DEVIATION 8.9 • n=7 Participants	28.3 kg/"m^2" STANDARD_DEVIATION 7.5 • n=5 Participants
Maternal age at delivery	32.4 yr STANDARD_DEVIATION 4.4 • n=5 Participants	30.1 yr STANDARD_DEVIATION 3.9 • n=7 Participants	31.1 yr STANDARD_DEVIATION 4 • n=5 Participants

PRIMARY outcome

Timeframe: One time sampling from the cord blood

Population: The number of the participants analyzed only included the levels for the female offspring.

The blood that were analyzed were taken from cord blood and not from the offspring.

Outcome measures

Measure	Control n=12 Participants Control	PCOS n=17 Participants Polycystic Ovary Syndrome
Estradiol Level in Female Offspring	18606 pg/ml Standard Deviation 18845	6467 pg/ml Standard Deviation 3989

PRIMARY outcome

Timeframe: cord blood

Population: The number of participants analyzed only included the levels of the female offspring.

Outcome measures

Measure	Control n=14 Participants Control	PCOS n=17 Participants Polycystic Ovary Syndrome
Androstenedione Level in Female Offspring	146 ng/dl Standard Deviation 104	87 ng/dl Standard Deviation 46

PRIMARY outcome

Timeframe: cord blood

Population: The number of participants analyzed only included the levels of the female offspring.

Outcome measures

Measure	Control n=14 Participants Control	PCOS n=16 Participants Polycystic Ovary Syndrome
Testosterone Level in Female Offspring	19 ng/dl Standard Deviation 29	7 ng/dl Standard Deviation 1

PRIMARY outcome

Timeframe: cord blood

Population: The number of participants analyzed only included the levels of the female offspring.

Outcome measures

Measure	Control n=14 Participants Control	PCOS n=17 Participants Polycystic Ovary Syndrome
17-hydroxyprogesterone Level in Female Offspring	2990 ng/dl Standard Deviation 1883	2777 ng/dl Standard Deviation 2103

PRIMARY outcome

Timeframe: cord blood

Population: The number of participants analyzed only included the levels of the female offspring.

Outcome measures

Measure	Control n=13 Participants Control	PCOS n=14 Participants Polycystic Ovary Syndrome
Dihydrotestosterone Level in Female Offspring	88 pg/ml Standard Deviation 75	137 pg/ml Standard Deviation 162

PRIMARY outcome

Timeframe: cord blood

Population: The number of participants analyzed only included the levels of the female offspring.

Outcome measures

Measure	Control n=11 Participants Control	PCOS n=10 Participants Polycystic Ovary Syndrome
Dehydroepiandrosterone Level in Female Offspring	5 ng/ml Standard Deviation 4	3 ng/ml Standard Deviation 2

PRIMARY outcome

Timeframe: birth

Population: Birth weight of the male and female infants.

Outcome measures

Measure	Control n=31 Participants Control	PCOS n=39 Participants Polycystic Ovary Syndrome
Infant Birth Weight (Male and Female)	3571 gram Standard Deviation 389	3539 gram Standard Deviation 597

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PCOS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrea Dunaif

Northwestern University

Phone: 312-503-2902

Email: a-dunaif@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place