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临床试验/NCT06212102
NCT06212102招募中2 期

Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation: A Randomized Controlled Non-inferiority Trial

Bedaya Hospital3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
120
试验地点
3
主要终点
Medications costs per retrieved oocyte

研究概览

简要总结

The aim of this randomized controlled trial is to compare the efficacy and cost-effectiveness of using progestin with GnRH antagonist to prevent premature LH surge in poor responders undergoing double stimulation protocol.

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
Single (Outcomes Assessor)

入排标准

年龄范围
35 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients belonging to Poseidon group 4

排除标准

  • Endometriosis
  • History of recurrent abortion

研究组 & 干预措施

GnRH antagonist group

Active Comparator

HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Flexible GnRH antagonist protocol (Cetrorelix acetate) (0.2 mg) was used to prevent premature LH surge during the FPS and LPS.

In subsequent cycle, frozen embryo transfer was done

干预措施: GnRH antagonist (Drug)

Progestin primed ovarian stimulation group

Experimental

HMG ( 300IU) was used during the follicular phase of ovarian stimulation (FPS) and during the luteal phase of ovarian stimulation (LPS). Progestin (dydrogesterone) 30 mg/day was used to prevent premature LH surge during the FPS and LPS.

In subsequent cycle, frozen embryo transfer was done

干预措施: Progestin primed ovarian stimulation (Drug)

结局指标

主要结局

Medications costs per retrieved oocyte

时间窗: Ten to fifteen days after starting ovarian stimulation]

Total cost of medications used in all cycles/number of retrieved oocytes

次要结局

  • Clinical pregnancy rate(5 weeks after embryo transfer])
  • Ongoing Pregnancy Rate(18 weeks after embryo transfer])

研究者

发起方
Bedaya Hospital
申办方类型
Other
责任方
Sponsor

研究点 (3)

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