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Trial record 4 of 30 for:    nichd Polycystic Ovary Syndrome (PCOS)

Intrauterine Environment in Polycystic Ovary Syndrome (PCOS) Probands

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ClinicalTrials.gov Identifier: NCT00364949
Recruitment Status : Completed
First Posted : August 16, 2006
Results First Posted : August 18, 2010
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):
Andrea Dunaif, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Condition Polycystic Ovary Syndrome
Enrollment 70

Recruitment Details letters to participants from other studies and patients from Ob/Gyn at Northwestern
Pre-assignment Details Exclusion based on personal/family history of diabetes or pre-existing medical condition
Arm/Group Title Control PCOS
Hide Arm/Group Description Control Polycystic Ovary Syndrome
Period Title: Overall Study
Started 31 39
Completed 31 39
Not Completed 0 0
Arm/Group Title Control PCOS Total
Hide Arm/Group Description Control Polycystic Ovary Syndrome Total of all reporting groups
Overall Number of Baseline Participants 31 39 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 39 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
31
 100.0%
39
 100.0%
70
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 39 participants 70 participants
Female
31
 100.0%
39
 100.0%
70
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 39 participants 70 participants
31 39 70
Pre-pregnancy BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/"m^2"
Number Analyzed 31 participants 39 participants 70 participants
25.1  (5.7) 30.8  (8.9) 28.3  (7.5)
Maternal age at delivery  
Mean (Standard Deviation)
Unit of measure:  Yr
Number Analyzed 31 participants 39 participants 70 participants
32.4  (4.4) 30.1  (3.9) 31.1  (4)
1.Primary Outcome
Title Estradiol Level in Female Offspring
Hide Description The blood that were analyzed were taken from cord blood and not from the offspring.
Time Frame One time sampling from the cord blood
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of the participants analyzed only included the levels for the female offspring.
Arm/Group Title Control PCOS
Hide Arm/Group Description:
Control
Polycystic Ovary Syndrome
Overall Number of Participants Analyzed 12 17
Mean (Standard Deviation)
Unit of Measure: pg/ml
18606  (18845) 6467  (3989)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, PCOS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Androstenedione Level in Female Offspring
Hide Description [Not Specified]
Time Frame cord blood
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed only included the levels of the female offspring.
Arm/Group Title Control PCOS
Hide Arm/Group Description:
Control
Polycystic Ovary Syndrome
Overall Number of Participants Analyzed 14 17
Mean (Standard Deviation)
Unit of Measure: ng/dl
146  (104) 87  (46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, PCOS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Testosterone Level in Female Offspring
Hide Description [Not Specified]
Time Frame cord blood
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed only included the levels of the female offspring.
Arm/Group Title Control PCOS
Hide Arm/Group Description:
Control
Polycystic Ovary Syndrome
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: ng/dl
19  (29) 7  (1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, PCOS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.156
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title 17-hydroxyprogesterone Level in Female Offspring
Hide Description [Not Specified]
Time Frame cord blood
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed only included the levels of the female offspring.
Arm/Group Title Control PCOS
Hide Arm/Group Description:
Control
Polycystic Ovary Syndrome
Overall Number of Participants Analyzed 14 17
Mean (Standard Deviation)
Unit of Measure: ng/dl
2990  (1883) 2777  (2103)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, PCOS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.770
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Primary Outcome
Title Dihydrotestosterone Level in Female Offspring
Hide Description [Not Specified]
Time Frame cord blood
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed only included the levels of the female offspring.
Arm/Group Title Control PCOS
Hide Arm/Group Description:
Control
Polycystic Ovary Syndrome
Overall Number of Participants Analyzed 13 14
Mean (Standard Deviation)
Unit of Measure: pg/ml
88  (75) 137  (162)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, PCOS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.325
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Primary Outcome
Title Dehydroepiandrosterone Level in Female Offspring
Hide Description [Not Specified]
Time Frame cord blood
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed only included the levels of the female offspring.
Arm/Group Title Control PCOS
Hide Arm/Group Description:
Control
Polycystic Ovary Syndrome
Overall Number of Participants Analyzed 11 10
Mean (Standard Deviation)
Unit of Measure: ng/ml
5  (4) 3  (2)
7.Primary Outcome
Title Infant Birth Weight (Male and Female)
Hide Description [Not Specified]
Time Frame birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Birth weight of the male and female infants.
Arm/Group Title Control PCOS
Hide Arm/Group Description:
Control
Polycystic Ovary Syndrome
Overall Number of Participants Analyzed 31 39
Mean (Standard Deviation)
Unit of Measure: gram
3571  (389) 3539  (597)
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and/or other (non-serious) adverse events were not assessed or collected because the cord blood sampling after the delivery of the offspring did not put anybody at risk.
 
Arm/Group Title Control PCOS
Hide Arm/Group Description Control Polycystic Ovary Syndrome
All-Cause Mortality
Control PCOS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control PCOS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/39 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control PCOS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/39 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Andrea Dunaif
Organization: Northwestern University
Phone: 312-503-2902
Responsible Party: Andrea Dunaif, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00364949     History of Changes
Other Study ID Numbers: P50HD044405 ( U.S. NIH Grant/Contract )
First Submitted: August 15, 2006
First Posted: August 16, 2006
Results First Submitted: July 19, 2010
Results First Posted: August 18, 2010
Last Update Posted: April 10, 2013