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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
letters to participants from other studies and patients from Ob/Gyn at Northwestern

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion based on personal/family history of diabetes or pre-existing medical condition

Reporting Groups
  Description
Control Control
PCOS Polycystic Ovary Syndrome

Participant Flow:   Overall Study
    Control   PCOS
STARTED   31   39 
COMPLETED   31   39 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Control
PCOS Polycystic Ovary Syndrome
Total Total of all reporting groups

Baseline Measures
   Control   PCOS   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   39   70 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   31   39   70 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   31   39   70 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   31   39   70 
Pre-pregnancy BMI 
[Units: Kg/"m^2"]
Mean (Standard Deviation)
 25.1  (5.7)   30.8  (8.9)   28.3  (7.5) 
Maternal age at delivery 
[Units: Yr]
Mean (Standard Deviation)
 32.4  (4.4)   30.1  (3.9)   31.1  (4) 


  Outcome Measures

1.  Primary:   Estradiol Level in Female Offspring   [ Time Frame: One time sampling from the cord blood ]

2.  Primary:   Androstenedione Level in Female Offspring   [ Time Frame: cord blood ]

3.  Primary:   Testosterone Level in Female Offspring   [ Time Frame: cord blood ]

4.  Primary:   17-hydroxyprogesterone Level in Female Offspring   [ Time Frame: cord blood ]

5.  Primary:   Dihydrotestosterone Level in Female Offspring   [ Time Frame: cord blood ]

6.  Primary:   Dehydroepiandrosterone Level in Female Offspring   [ Time Frame: cord blood ]

7.  Primary:   Infant Birth Weight (Male and Female)   [ Time Frame: birth ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: a-dunaif@northwestern.edu



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