AMH and Dosing Regimens for Initial IVF Stimulation Protocols
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
This is a research study on a hormone in women called anti-mullerian hormone (AMH) an indicator of the amount of egg reserve in the ovaries. The research involves a blood draw to determine the AMH level. This knowledge will help the investigators decide a dosage of gonadotropins, the hormones used to stimulate the production of more than one egg for use in an in vitro fertilization (IVF) cycle. The amount of gonadotropin given has to be tailored to each individual participant. The investigators can use information about the participant and the hormone levels to determine this dosage and the chances of becoming pregnant as a result of IVF treatment. The reason the investigators are doing this research is to find out if basing the gonadotropin dosage solely on the participant's AMH level will give the investigators a better result than the previous method based on age and other hormone levels.
详细描述
Background / Rationale Anti-Müllerian Hormone (AMH) has been established as a valuable biomarker of ovarian reserve. It is a glycoprotein produced by granulosa cells of the ovary; it regulates the development of the primary follicle while inhibiting further recruitment of other surrounding follicles. Day 3 FSH and basal antral follicle count have traditionally been used to assess ovarian reserve and while they remain excellent predictors of poor ovarian response, they have not been shown to predict IVF success rates. Given the association between AMH and ovarian reserve, it has been proposed that AMH level can be used to predict ovarian response to gonadotropin stimulation and also, IVF success rates. An inverse relationship between AMH and total gonadotropin dosage has previously been demonstrated. As such, the concept of tailoring stimulation protocols to the patient's potential for oocyte production based on AMH level has gained favor. Individualization allows the practitioner to use the minimum dosage of medication required for maximum response, while limiting the risk of ovarian hyperstimulation syndrome. The question becomes how to determine the dosage of medication required for each AMH level and what effect will this have on clinical outcomes?
Hypothesis 1) Knowledge of AMH level used to determine medication dosage at the start of the stimulation cycle will result in a higher oocyte yield at the time of retrieval, higher clinical pregnancy rate, and higher live birth rate.
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Knowledge of AMH level used to determine initial medication dosage at the start of the stimulation cycle will result in a fewer number of dosage changes mid-cycle.
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Knowledge of AMH level prior to the start of a stimulation cycle will result in the use of a different initial stimulation dose compared to cycles in which the AMH is unknown.
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Knowledge of AMH level used to determine medication dosage prior to the start of the stimulation cycle will result in a lower rate of ovarian hyperstimulation syndrome (OHSS). (Defined as >=20 oocytes/follicles) 5) Knowledge of AMH level used to determine medication dosage prior to the start of the stimulation cycle will result in a lower rate of cancelled cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 43 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •first cycle of IVF with transfer of fresh embryo
排除标准
- •use of non-autologous oocytes; prior diagnosis of premature ovarian failure or diminished ovarian reserve; BMI>= 40; cryopreservation cycles; smokers; use of PGS/PGD; use of surgically retrieved sperm or patients with severe male factor; and oocyte- or embryo-banking cycles
研究组 & 干预措施
AMH<1.5, 300IU Gonal-F + 150 IU Menopur
dosage at 300IU Gonal-F + 150IU Menopur
干预措施: 300IU Gonal-F (Drug)
AMH<1.5, 300IU Gonal-F + 150 IU Menopur
dosage at 300IU Gonal-F + 150IU Menopur
干预措施: 150IU Menopur (Drug)
AMH 1.6-2.5, 225IU Gonal-F+75IU Menopur
dosage of 225IU Gonal-F + 75IU Menopur
干预措施: 225IU Gonal-F (Drug)
AMH 1.6-2.5, 225IU Gonal-F+75IU Menopur
dosage of 225IU Gonal-F + 75IU Menopur
干预措施: 75IU Menopur (Drug)
AMH 2.6-6.9, 150IU Gonal-F+75IU Menopur
start dosage of 150IU Gonal-F and 75IU Menopur
干预措施: 75IU Menopur (Drug)
AMH 2.6-6.9, 150IU Gonal-F+75IU Menopur
start dosage of 150IU Gonal-F and 75IU Menopur
干预措施: 150IU Gonal-F (Drug)
AMH >=7.0, 75IU Gonal-F+75U Menopur
start dosage of 75IU Gonal-F and 75U Menopur
干预措施: 75IU Menopur (Drug)
AMH >=7.0, 75IU Gonal-F+75U Menopur
start dosage of 75IU Gonal-F and 75U Menopur
干预措施: 75IU Gonal-F (Drug)
结局指标
主要结局
clinical pregnancy rate
时间窗: two years
Clinical pregnancy rate is defined as the number of pregnancies with the presence of an intrauterine gestational sac seen on transvaginal ultrasound by six weeks gestation divided by the number of completed embryo transfers.
次要结局
- Oocyte yield(two years)
