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The current study aims to investigate the dynamic serum kisspeptin levels throughout pregnancy and to explore its predictive value for GDM in PCOS.
The current prospective cohort study aims to investigate the dynamic serum kisspeptin levels in the patients with polycystic ovary syndrome (PCOS) at different trimesters of pregnancy, to analyze the associations between serum kisspeptin, insulin, glucose and testosterone, and to explore the predictive value of kisspeptin for GDM and other complications in PCOS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCOS group | Pregnant women between 18 and 40 years old who were diagnosed as polycystic ovary syndrome before pregnancy, registered in the OB & GYN Hospital of Fudan University for prenatal check during the first trimester. The diagnostic criteria for PCOS are based on the 2003 Rotterdam diagnostic criteria. Exclude healthy women with all other diseases that may have ovulation disorders or hyperandrogenism; There are other serious illnesses or complications present; Other endocrine disorders exist: thyroid diseases such as hyperthyroidism or hypothyroidism; During pregnancy, medication that may affect Kisspeptin or insulin levels, such as metformin or insulin therapy, is being used; |
| |
| Control group | Healthy pregnant women between 18 and 40 years old women without a history of PCOS. Exclude healthy women with all other diseases that may have ovulation disorders or hyperandrogenism; There are other serious illnesses or complications present; Other endocrine disorders exist: thyroid diseases such as hyperthyroidism or hypothyroidism; During pregnancy, medication that may affect Kisspeptin or insulin levels, such as metformin or insulin therapy, is being used; |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | It's a observational cohort study and no interventions are performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic changes of serum kisspeptin levels throughout pregnancy in PCOS patients | Serum kisspeptin levels in the first, second trimester and late pregnancy of PCOS patients and control group. | 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The association between serum Kisspeptin levels and the prevalence of GDM in PCOS patients | The predictive value of serum Kisspeptin levels in the first trimester for GDM in PCOS patients | 40 weeks |
| The association between serum Kisspeptin levels and the prevalence of insulin resistance in PCOS patients |
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Inclusion Criteria:
Exclusion Criteria:
Positive pregnancy test and confirmed intrauterine singleton pregnancy by ultrasound
The characteristics of patients with polycystic ovary syndrome include amenorrhea or infrequent menstruation, high hormone levels, and polycystic ovary like changes in the ovaries. Usually accompanied by fertility disorders and metabolic disorders, PCOS patients face a higher risk of pregnancy complications during pregnancy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhang, phD | Contact | +8613611691036 | zhangwei623@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hexia Xia, M.D. | The Obstetrics & Gynecology Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OB & GYN Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D011248 | Pregnancy Complications |
| D016640 | Diabetes, Gestational |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Serum kisspeptin, insulin, testosterone and blood glucose in the first trimester, second trimester and late pregnancy.
The predictive value of serum Kisspeptin levels in the first trimester for insulin resistance in PCOS patients |
| 40 weeks |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |