CoPPer Study - Complications of Polycystic Ovary Syndrome (PCOS) Pregnancy: Evaluating Risk

NCT00821379 | Completed

• 2 other identifiers: CoPPer study - 07/331NL 20244.041.07 (ABR)
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The CoPPer study is a follow-up study of women diagnosed with Polycystic Ovary Syndrome (PCOS). Women will be included pre-conceptional and followed-up until after delivery. The investigators will design a multivariate prediction model of pregnancy outcome in women with PCOS with the intention to define intervention strategies for the future.

Conditions

Pregnancy Complications; Delivery Complications; Neonatal Complications

Keywords

PCOS; Polycystic Ovary Syndrome; Pregnancy Complications; Gestational Diabetes; Pre eclampsia; Prediction Model; Pre conceptional

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with PCOS and a wish to conceive who attend to the University Hospital in Utrecht.

You may qualify if:

• Women with PCOS
• to 40 years old, who wish to conceive.

You may not qualify if:

• Women with anovulation that is not caused by PCOS
• Women with a language barrier
• Women under 18 or over 40 years of age will be excluded from participation.
• Unresolved medical conditions
• Established type 1 diabetes.

Sponsors & Collaborators

• UMC Utrecht: lead
• The Queen Elizabeth Hospital: collaborator
• Erasmus Medical Center: collaborator
• Amsterdam UMC, location VUmc: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3508 GA, Netherlands

Location

Related Publications (9)

• Christ JP, Gunning MN, Meun C, Eijkemans MJC, van Rijn BB, Bonsel GJ, Laven JSE, Fauser BCJM. Pre-Conception Characteristics Predict Obstetrical and Neonatal Outcomes in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2019 Mar 1;104(3):809-818. doi: 10.1210/jc.2018-01787.

  PMID: 30590587 DERIVED

• de Wilde MA, Lamain-de Ruiter M, Veltman-Verhulst SM, Kwee A, Laven JS, Lambalk CB, Eijkemans MJC, Franx A, Fauser BCJM, Koster MPH. Increased rates of complications in singleton pregnancies of women previously diagnosed with polycystic ovary syndrome predominantly in the hyperandrogenic phenotype. Fertil Steril. 2017 Aug;108(2):333-340. doi: 10.1016/j.fertnstert.2017.06.015.

  PMID: 28778282 DERIVED

• Daan NM, Koster MP, Steegers-Theunissen RP, Eijkemans MJ, Fauser BC. Endocrine and cardiometabolic cord blood characteristics of offspring born to mothers with and without polycystic ovary syndrome. Fertil Steril. 2017 Jan;107(1):261-268.e3. doi: 10.1016/j.fertnstert.2016.09.042. Epub 2016 Oct 27.

  PMID: 28228318 DERIVED

• Koster MP, de Wilde MA, Veltman-Verhulst SM, Houben ML, Nikkels PG, van Rijn BB, Fauser BC. Placental characteristics in women with polycystic ovary syndrome. Hum Reprod. 2015 Dec;30(12):2829-37. doi: 10.1093/humrep/dev265. Epub 2015 Oct 25.

  PMID: 26498178 DERIVED

• de Wilde MA, Goverde AJ, Veltman-Verhulst SM, Eijkemans MJ, Franx A, Fauser BC, Koster MP. Insulin action in women with polycystic ovary syndrome and its relation to gestational diabetes. Hum Reprod. 2015 Jun;30(6):1447-53. doi: 10.1093/humrep/dev072. Epub 2015 Apr 2.

  PMID: 25840428 DERIVED

• de Wilde MA, Veltman-Verhulst SM, Goverde AJ, Lambalk CB, Laven JS, Franx A, Koster MP, Eijkemans MJ, Fauser BC. Preconception predictors of gestational diabetes: a multicentre prospective cohort study on the predominant complication of pregnancy in polycystic ovary syndrome. Hum Reprod. 2014 Jun;29(6):1327-36. doi: 10.1093/humrep/deu077. Epub 2014 Apr 28.

  PMID: 24777850 DERIVED

• Veltman-Verhulst SM, Goverde AJ, van Haeften TW, Fauser BC. Fasting glucose measurement as a potential first step screening for glucose metabolism abnormalities in women with anovulatory polycystic ovary syndrome. Hum Reprod. 2013 Aug;28(8):2228-34. doi: 10.1093/humrep/det226. Epub 2013 Jun 5.

  PMID: 23739218 DERIVED

• Veltman-Verhulst SM, Fauser BC, Eijkemans MJ. High singleton live birth rate confirmed after ovulation induction in women with anovulatory polycystic ovary syndrome: validation of a prediction model for clinical practice. Fertil Steril. 2012 Sep;98(3):761-768.e1. doi: 10.1016/j.fertnstert.2012.04.027. Epub 2012 May 24.

  PMID: 22633255 DERIVED

• Veltman-Verhulst SM, van Haeften TW, Eijkemans MJ, de Valk HW, Fauser BC, Goverde AJ. Sex hormone-binding globulin concentrations before conception as a predictor for gestational diabetes in women with polycystic ovary syndrome. Hum Reprod. 2010 Dec;25(12):3123-8. doi: 10.1093/humrep/deq272. Epub 2010 Oct 13.

  PMID: 20943702 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum and lithium heparine, urine and placenta tissue

MeSH Terms

Conditions

Pregnancy Complications; Polycystic Ovary Syndrome; Diabetes, Gestational; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypertension, Pregnancy-Induced

Study Officials

• Bart CJ Fauser, MD PhD

  UMC Utrecht

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 13, 2009
• Study Start: April 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: September 1, 2012
• Last Updated: December 20, 2012

Record last verified: 2009-01

Locations

NL (1)