Dataset Information

The Pregnancy in Polycystic Ovary Syndrome II study: baseline characteristics and effects of obesity from a multicenter randomized clinical trial.

ABSTRACT:

Objective

To summarize baseline characteristics from a large multicenter infertility clinical trial.

Design

Cross-sectional baseline data from a double-blind randomized trial of two treatment regimens (letrozole vs. clomiphene).

Setting

Academic Health Centers throughout the United States.

Patient(s)

Seven hundred fifty women with polycystic ovary syndrome (PCOS) and their male partners took part in the study.

Intervention(s)

None.

Main outcome measure(s)

Historic, biometric, biochemical, and questionnaire parameters.

Result(s)

Females averaged 30 years and were obese (body mass index [BMI] 35) with ?20% from a racial/ethnic minority. Most (87%) were hirsute and nulligravid (63%). Most of the women had an elevated antral follicle count and enlarged ovarian volume on ultrasound. Women had elevated mean circulating androgens, LH-to-FSH ratio (?2), and antimüllerian hormone levels (8.0 ng/mL). In addition, women had evidence for metabolic dysfunction with elevated mean fasting insulin and dyslipidemia. Increasing obesity was associated with decreased LH-to-FSH levels, antimüllerian hormone levels, and antral follicle counts but increasing cardiovascular risk factors, including prevalence of the metabolic syndrome. Men were obese (BMI 30) and had normal mean semen parameters.

Conclusion(s)

The treatment groups were well matched at baseline. Obesity exacerbates select female reproductive and most metabolic parameters. We have also established a database and sample repository that will eventually be accessible to investigators.

Clinical trial registration number

NCT00719186.

SUBMITTER: Legro RS

PROVIDER: S-EPMC3899700 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The Pregnancy in Polycystic Ovary Syndrome II study: baseline characteristics and effects of obesity from a multicenter randomized clinical trial.

Legro Richard S RS Brzyski Robert G RG Diamond Michael P MP Coutifaris Christos C Schlaff William D WD Alvero Ruben R Casson Peter P Christman Gregory M GM Huang Hao H Yan Qingshang Q Haisenleder Daniel J DJ Barnhart Kurt T KT Bates G Wright GW Usadi Rebecca R Lucidi Richard R Baker Valerie V Trussell J C JC Krawetz Stephen A SA Snyder Peter P Ohl Dana D Santoro Nanette N Eisenberg Esther E Zhang Heping H

Fertility and sterility 20131021 1

<h4>Objective</h4>To summarize baseline characteristics from a large multicenter infertility clinical trial.<h4>Design</h4>Cross-sectional baseline data from a double-blind randomized trial of two treatment regimens (letrozole vs. clomiphene).<h4>Setting</h4>Academic Health Centers throughout the United States.<h4>Patient(s)</h4>Seven hundred fifty women with polycystic ovary syndrome (PCOS) and their male partners took part in the study.<h4>Intervention(s)</h4>None.<h4>Main outcome measure(s)</ ...[more]

PMID: 24156957

Similar Datasets

Project description:Polycystic ovary syndrome (PCOS) is a common metabolic problem in women of reproductive age. Evidence suggests pregnant women with PCOS may have a higher risk of the development of adverse pregnancy outcomes; however, the relationship between pre-pregnancy overweight/obesity and pregnancy outcomes in women with PCOS remains uncertain. We try to clarify the relationship between pre-pregnancy overweight/obesity and subsequent pregnancy outcomes. Therefore, we conducted this systematic review and meta-analysis. We used the databases obtained from the PubMed, Embase, Web of Science, and Cochrane databases, plus hand-searching, to examine the association between pre-pregnancy overweightness/obesity and pregnancy outcomes in women with PCOS from inception to 4 February 2022. A total of 16 cohort studies, including 14 retrospective cohort studies (n = 10,496) and another two prospective cohort studies (n = 818), contributed to a total of 11,314 women for analysis. The meta-analysis showed significantly increased odds of miscarriage rate in PCOS women whose pre-pregnancy body mass index (BMI) is above overweight (OR 1.71 [95% CI 1.38-2.11]) or obese (OR 2.00 [95% CI 1.38-2.90]) under a random effect model. The tests for subgroup difference indicated the increased risk was consistent, regardless which body mass index cut-off for overweight (24 or 25 kg/m2) or obesity (28 and 30 kg/m2) was used. With the same strategies, we found that pregnant women in the control group significantly increased live birth rate compared with those pregnant women with PCOS as well as pre-pregnancy overweight/obesity (OR 0.79 [95% CI 0.71-0.89], OR 0.78 [95% CI 0.67-0.91]). By contrast, we did not find any association between PCOS women with pre-pregnancy overweight/obesity and preterm birth. Based on the aforementioned findings, the main critical factor contributing to a worse pregnancy outcome may be an early fetal loss in these PCOS women with pre-pregnancy overweight/obesity. Since PCOS women with pre-pregnancy overweightness/obesity were associated with worse pregnancy outcomes, we supposed that weight reduction before attempting pregnancy in the PCOS women with pre-pregnancy overweightness/obesity may improve the subsequent pregnancy outcomes.

Project description:BACKGROUND: Polycystic ovary syndrome (PCOS) is a heterogeneous endocrine disorder frequently accompanied by obesity and by insulin resistance, and patients with this syndrome suffer from infertility and poor pregnancy outcome. Disturbances in plasma amino acid (AA) metabolism have been implicated in women with PCOS. However, direct evidence on follicular AA metabolic profiles in PCOS patients and their relationship with pregnancy outcome is sparse. METHODS: We conducted a prospective study in 63 PCOS patients and 48 controls in the Division of Reproductive Center, Peking University Third Hospital. Follicular AA levels were measured by the liquid chromatography-tandem mass spectrometric method, and the results were analyzed based on different grouping criteria. RESULTS: The levels of aromatic amino acid (AAA) increased in PCOS patients independent of obesity (P < 0.05), whereas the levels of branched-chain amino acid (BCAA), glutamic acid, phenylalanine, alanine, and arginine increased with body mass index irrespective of the PCOS status (all P < 0.05). In addition, compared with non insulin resistant-PCOS patients and controls, insulin resistant-PCOS group had higher levels of leucine, valine and glutamic acid (all P < 0.05). In PCOS group, aspartic acid and serine levels were elevated in pregnant patients compared with the non-pregnant subjects (both P < 0.05). Moreover, the levels of BCAA and valine were higher in the non-pregnant group than in the pregnant group (both P < 0.05). The pregnancy rate (45.00%) of subjects with elevated BCAA level was significantly lower than that (66.67%) in control subjects (P = 0.036) at a BCAA cutoff value of 239.10 μM, while the abortion rate was much higher (33.33% versus 2.78%, P = 0.004). CONCLUSIONS: Both PCOS and obesity were accompanied by follicular AA metabolic disturbances, with obesity exerting a more pronounced effect on AA metabolic profiles. The disruptions in specific AAs in the follicular fluid might account for the inferior pregnancy outcome in obese patients and increased risk of abortion in PCOS patients.

Dataset Information

The Pregnancy in Polycystic Ovary Syndrome II study: baseline characteristics and effects of obesity from a multicenter randomized clinical trial.

Objective

Design

Setting

Patient(s)

Intervention(s)

Main outcome measure(s)

Result(s)

Conclusion(s)

Clinical trial registration number

Publications

The Pregnancy in Polycystic Ovary Syndrome II study: baseline characteristics and effects of obesity from a multicenter randomized clinical trial.

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