Long-term Follow-Up of Infertility Patients: A Pilot Study

不孕症患者的长期随访：一项试点研究

• 批准号: 7899947
• 负责人: FRANCINE GRODSTEIN
• 金额: $ 20.75万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-01 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7899947
• 关键词: Affect; Age; Benign; Biological Markers; Blood Vessels; Blood specimen; Breast Diseases; Cardiovascular Diseases; Clinic; Clinical; Data; Data Collection; Descriptive Epidemiology; Development; Dose; Drug usage; Embryo Transfer; Estrogens; Fertilization; Fertilization in Vitro; Gonadotropins; Health; Health Professional; Healthcare; Hormonal; Hormones; Hypertension; In Vitro; Infertility; Infertility study; Insemination; Knowledge; Lead; Malignant Neoplasms; Nurses' Health Study; Oral Contraceptives; Outcome; Ovarian Stimulations; Participant; Patients; Pharmaceutical Preparations; Pilot Projects; Postmenopause; Prevalence; Questionnaires; Recording of previous events; Reporting; Research; Risk; Text; Time; Woman; aged; cohort; common treatment; follow-up; high risk; hormone therapy; public health relevance; reproductive

DESCRIPTION (provided by applicant): Infertility affects approximately 12% of women aged 15-44 years; this prevalence increases to about 30% in women over age 35 years. In 2002, approximately 1% of all babies born in the US were a result of in- vitro fertilization (IVF). The gonadotropin drugs used in ovarian stimulation are potent, and lead to estrogen levels as much as 5-15 times higher than those typical for reproductive-age women. Multiple stimulation cycles have become increasingly common, especially since the mid to late nineties, as clinics have attempted to reduce the number of embryos transferred during IVF. Although health effects of hormonal treatments such as oral contraceptives and postmenopausal hormone therapy have been well- documented, surprisingly little is known regarding the long-term consequences of infertility treatments. Thus, we propose to conduct a pilot study exploring the possibility of initiating research on infertility treatment in relation to long-term health within participants of the ongoing Nurses' Health Study II. The Nurses' Health Study II includes 118,000 women, aged 25-42 years when the study started in 1989; since 1995, 9,200 women have reported a history of infertility, with 1,900 reporting use of gonadotropin drugs. The Nurses' Health Study II cohort has important advantages in studying infertility treatment, since confounding due to healthcare knowledge and access may be minimized in these health professionals. Specifically, we propose to: (1) develop and validate a supplementary questionnaire for participants with a history of infertility, to collect data on treatment history and utilization, and other relevant information; and (2) conduct preliminary analyses, including exploration of any increased risk of hypertension associated with gonadotropin use, and any increased risk of benign breast disease (both of these are common outcomes, with adequate power to detect relations after a modest follow-up period). Overall, this proposed pilot study has the potential to lead to substantial research on a wide variety of issues related to IVF and infertility treatment. For example, within the Nurses' Health Study II, we could eventually consider further outcomes, such as vascular biomarkers, taking advantage of blood samples which were collected from the subjects. In addition, over the years, with further follow-up, we could examine clinical cardiovascular disease, various cancers, etc. PUBLIC HEALTH RELEVANCE: Infertility affects approximately 12% of women aged 15-44 years. In 2002, one % of babies born in the US were a result of in-vitro fertilization (IVF). The gonadotropin drugs used in ovarian stimulation are potent, and lead to estrogen levels as much as 5-15 times higher than those typical for reproductive- age women. Although health effects of hormonal treatments such as oral contraceptives have been well-documented, little is known regarding the long-term consequences of infertility treatments. Thus, we propose to conduct a pilot study exploring the possibility of initiating research on infertility treatment in relation to long-term health within participants of the ongoing Nurses' Health Study II.

描述（由申请人提供）：不育症影响约12％的15-44岁妇女； 35岁以上的女性，这种流行率增加到约30％。 2002年，在美国出生的所有婴儿中，大约有1％是体外受精（IVF）的结果。卵巢刺激中使用的促性腺激素药物有效，导致雌激素水平是生殖时代女性典型的雌激素水平高达5-15倍。由于诊所试图减少IVF期间转移的胚胎数量，因此多个刺激周期变得越来越普遍，尤其是自九十年代中期以来。尽管诸如口服避孕药和绝经后激素疗法之类的荷尔蒙治疗的健康作用已得到充分证明，但令人惊讶的是，关于不育治疗的长期后果知之甚少。因此，我们建议进行一项试点研究，以探讨与正在进行的护士健康研究参与者内长期健康有关的不孕治疗研究的可能性。护士健康研究II包括118,000名妇女，年龄在1989年开始的25-42岁；自1995年以来，有9,200名妇女报告了不育病史，有1,900名报告使用促性腺激素药物。护士健康研究II队列在研究不孕治疗方面具有重要的优势，因为这些卫生专业人员可能会最小化由于医疗保健知识和获得的混淆。具体而言，我们建议：（1）为具有不育历史的参与者制定并验证一份补充问卷，以收集有关治疗史和利用率的数据以及其他相关信息； （2）进行初步分析，包括探索与促性腺激素使用相关的高血压风险的增加，以及任何良性乳房疾病的风险增加（这都是常见的结果，并在适度的随访期后具有足够的能力来检测关系）。总体而言，这项拟议的试点研究有可能导致对与IVF和不育治疗有关的各种问题进行大量研究。例如，在护士健康研究II中，我们最终可以考虑进一步的结果，例如血管生物标志物，利用从受试者那里收集的血液样本。此外，多年来，随着进一步的随访，我们可以检查临床心血管疾病，各种癌症等。公共卫生相关性：不育会影响约12％的15-44岁妇女。 2002年，美国出生的婴儿中有1％是维特罗施肥（IVF）的结果。卵巢刺激中使用的促性腺激素药物有效，导致雌激素水平高达典型的生殖年龄女性5-15倍。虽然健康影响 诸如口服避孕药等荷尔蒙治疗已得到充分证明，关于不育治疗的长期后果知之甚少。因此，我们建议进行一项试点研究，以探讨与正在进行的护士健康研究参与者内长期健康有关的不孕治疗研究的可能性。