Effects of Peri-Implantation Sexual Abstinence on Placentation and Its Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Placental Malondialdehyde Concentration
研究概览
简要总结
This study examined whether avoiding sexual intercourse during the time when a fertilized egg may attach to the uterus affects placental development and pregnancy outcomes. Couples who were trying to conceive naturally were assigned by chance to one of two groups. Couples in the abstinence group were asked to avoid sexual intercourse for 14 days after ovulation. Couples in the no-restriction group continued their usual sexual activity without a study-imposed restriction. Participants were followed to determine whether pregnancy occurred and, when applicable, through pregnancy and delivery. During pregnancy, ultrasound was used to assess blood flow between the pregnant participant, placenta, and fetus. After delivery, available placentas were examined for tissue changes, blood-vessel development, and markers of oxidative stress, which reflects the balance between potentially damaging oxidants and the body's antioxidant defenses. Pregnancy and birth outcomes were also recorded. The study was designed to improve understanding of whether sexual activity around the time of implantation may be associated with placental development and pregnancy outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 20 to 40 years
- •Attempting to conceive naturally
- •Regular menstrual cycles of 28 to 30 days
- •No history of major medical or gynecological disorders
- •Willingness of both partners to provide written informed consent and follow the assigned study procedures
排除标准
- •Polycystic ovary syndrome
- •Endometriosis
- •Current or previous tobacco use
- •Current or previous alcohol use
- •Body mass index below 18.5 or above 30 kg/m²
- •Cardiovascular disease
- •Chronic hypertension
- •Chronic respiratory disease
- •Chronic renal disease
- •Diabetes mellitus
- •Previous pre-eclampsia
- •Previous lower-segment cesarean section
- •Previous dilatation and curettage
- •Previous myomectomy
研究组 & 干预措施
Abstinence
Couples assigned to this arm were instructed to avoid sexual intercourse for 14 days after ovulation during each study cycle. The abstinence period covered the expected peri-implantation window.
干预措施: Couples were instructed to avoid sexual intercourse for 14 days after ovulation during each study cycle, covering the expected peri-implantation period. (Behavioral)
结局指标
主要结局
Placental Malondialdehyde Concentration
时间窗: At delivery
Malondialdehyde concentration was measured in placental tissue as an indicator of lipid peroxidation and normalized to total placental protein. The outcome was reported in nanomoles per milligram of protein.
Placental Villous Microvessel Density Assessed by CD31 Immunohistochemistry
时间窗: At delivery
Placental villous microvessel density was measured as the mean number of CD31-positive microvessels per high-power field in placental tissue collected after delivery. CD31-positive structures were quantified using a prespecified QuPath-assisted digital image-analysis procedure by assessors blinded to study allocation.
Placental Superoxide Dismutase Activity
时间窗: At delivery
Superoxide dismutase activity was measured in placental tissue as an indicator of enzymatic antioxidant activity and normalized to total placental protein. The outcome was reported in units per milligram of protein.
Placental Catalase Activity
时间窗: At delivery
Catalase activity was measured in placental tissue as an indicator of enzymatic antioxidant activity and normalized to total placental protein. The outcome was reported in units per milligram of protein. .
Placental Total Antioxidant Capacity
时间窗: At delivery
Total antioxidant capacity was measured in placental tissue and normalized to total placental protein. The outcome was reported in micromoles per milligram of protein
次要结局
未报告次要终点
研究者
Abubakar Ibrahim
Postgraduate Researcher, Department of Obstetrics and Gynaecology
Universiti Sains Malaysia