Optimizing Ovulation Induction in the Poor Responder: a Randomized Clinical Trial of Luteal Phase Estradiol Versus Combined Oral Contraceptive Pill on Ovarian Morphology and Biomarkers Prior to Ovulation Induction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Follicular response and synchrony
研究概览
简要总结
The purpose of this randomized controlled trial is to compare the efficacy and effect of luteal estradiol and combined oral contraceptive pills (COPC) on follicle recruitment and synchrony in a poor responder population. The randomized groups consist of: 1. patients receiving luteal estradiol prior to ovulation induction; and 2. patients receiving COCPs for 1 month prior to ovulation induction. Follicle characteristics and serum biomarkers will be followed and compared in each group. Coefficient of variation will be used to evaluate follicle size discrepancy. Chi square analysis will be used to compare categorical variables between treatment groups. Both estradiol and COPCs are used clinically in assisted reproduction, so this study affords no additional risks to the participants.
详细描述
- Protocol Title:
Optimizing ovulation induction in the poor responder: a randomized controlled trial of luteal phase estradiol verses combined oral contraceptive pill (COCP) on ovarian morphology and biomarkers prior to ovulation induction 2. Purpose of the Study:
In women undergoing ovulation induction who are at high risk for poor response, we hypothesize that:
Null Hypothesis: Mean follicular diameter and coefficient of variation between follicles in patients receiving luteal COCP are statistically equal to follicular diameters and coefficient of variation between follicles in patients receiving estradiol. To test this hypothesis, the specific aims of the present proposal are:
Aim 1: Compare the effect of luteal estradiol and COCP pretreatment on follicle synchrony. Mean follicular diameter and the coefficient of variation between follicle measurements will be calculated on cycle day 3 the cycle before and during treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Antral follicle count < 8
- •Antimullerian hormone (AMH) <1.3
- •Follicle stimulating hormone (FSH)>10
- •History of follicular dysynchrony or poor response
排除标准
- •Menopause
- •Age > 50
- •Contraindication to estradiol or COCP (including pre-existing cardiovascular disease, familial thrombophilia (factor V Leiden), severe hypercholesterolemia, smoker over age 35) Ovulation induction during month of estradiol treatment
研究组 & 干预措施
Oral Contraceptive Pills (OCP)
This group of patients will receive OCP's prior to the IVF cycle.
干预措施: Oral Contraceptive Pills (OCP) (Drug)
Estradiol Patch
This group of patients will receive estradiol patches prior to the IVF cycle.
干预措施: Estradiol (Drug)
结局指标
主要结局
Follicular response and synchrony
时间窗: 2 years
We will measure follicular response and synchrony following adminstration of extradiol patches or oral contraceptive pills.
次要结局
- IVF outcomes(2 years)