Androgen Metabolism and Reproductive Outcome

Study Overview
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Brief Summary
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The aim of this study is to determine maternal androgen metabolism during pregnancy and the impact of androgen disorders on mothers and infants.

Detailed Description
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Women with polycystic ovary syndrome (PCOS) have an impaired fertility and significant higher complication rates during infertility treatment, pregnancy and the perinatal period. Complications include the occurrence of multiple gestations, ovarian hyper stimulation syndrome, early pregnancy loss, gestational diabetes, pregnancy-induced hypertension, pre-eclampsia and need for caesarean section. Moreover, their infants are more frequently born preterm, have higher perinatal mortality rates and are more often admitted to a neonatal intensive care unit. The etiology of PCOS is not particularly mapped, but a genetic background can be assumed by analyzing PCOS families. In utero androgen excess has also been suspected to be an important risk factor. Animal studies have demonstrated that intrauterine hyperandrogenic environment affects the offspring by leading to biochemical and morphological features of PCOS. Sex differences in prenatal androgen levels have been observed and testosterone levels in umbilical cord blood and in amniotic fluid are higher in healthy male babies than in healthy female babies. There are just a few reporting on the relation between maternal androgen levels during pregnancy and the respective offspring. The aim of this clinical study is to determine maternal androgen metabolism and the impact of androgen disorders on mothers and infants.

Official Title
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Androgen Metabolism and Reproductive Outcome

Conditions
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Polycystic Ovary Syndrome, Healthy Pregnant Women

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women with and without PCOS Exclusion Criteria: unable to consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women with PCOS and offspring<br>Exposures of interest: Polycystic ovary Syndrome (PCOS) according to Rotterdam | |
| Pregnant women without PCOS and offspring<br>Exposures of interest: Pregnant women without polycystic ovary Syndrome (PCOS) according to Rotterdam | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of testosterone between mother and offspring |  | day of birth (within average 24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of sexual hormon binding globulin between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of thyroid-stimulating hormone between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of androstendione between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of anti muellerian hormon between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of progesterone between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of dehydroepiandrosteron between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of Vitamin D levels between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of prolactin between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of insulin between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of human growth hormon between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of c-peptide between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of cortisol between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of luteinizing hormon between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of follicle stimulating hormone between mother and offspring |  | day of birth (within average 24 hours) | 
| correlation of estrogen levels between mother and offspring |  | day of birth (within average 24 hours) | 
| maternal testosterone |  | six weeks after birth | 
| maternal sexual hormon binding globulin |  | six weeks after birth | 
| maternal thyroid-stimulating hormone |  | six weeks after birth | 
| maternal androstendione |  | six weeks after birth | 
| maternal anti muellerian hormon |  | six weeks after birth | 
| maternal progesterone |  | six weeks after birth | 
| maternal dehydroepiandrosteron |  | six weeks after birth | 
| maternal Vitamin D levels |  | six weeks after birth | 
| maternal prolactin |  | six weeks after birth | 
| maternal insulin |  | six weeks after birth | 
| maternal human growth hormon |  | six weeks after birth | 
| maternal c-peptide |  | six weeks after birth | 
| maternal cortisol |  | six weeks after birth | 
| maternal luteinizing hormon |  | six weeks after birth | 
| maternal follicle stimulating hormone |  | six weeks after birth | 
| maternal estrogen levels |  | six weeks after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polycystic ovary Syndrome, hyperandrogenism, cordblood, androgens