To Evaluate the Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes in Both GnRH Agonist and GnRH Antagonist Treated Ovarian Stimulation Protocols
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Live Birth Rate
研究概览
简要总结
This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol.
详细描述
This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol. Decision between each of these two protocols was subjective and depended on the clinical context.In addition to routine luteal phase support with progesterone and estradiol valerate,women received two dose of GnRH agonist on the fifth and tenth day after ET.Live birth rate was the primary outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Couples undergoing ART with their own gametes.
- •Couples having at least one good embryo available for transfer.
- •Normoresponder
- •Infertility etiology is unexplained
- •ovulation triggered by intramuscular injection of 10000 IU of HCG
排除标准
- •Patients older than 38 years old
- •High and poor responder patients
研究组 & 干预措施
LongGnRH agonist protocol(controlgroup)
Long GnRH agonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate
干预措施: vaginal progesterone (Drug)
LongGnRH agonist protocol(controlgroup)
Long GnRH agonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate
干预措施: 4 mg oral estradiol valerate (Drug)
antagonist protocol-leuprolide acetate
GnRH antagonist protocol Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate + subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
干预措施: Leuprolide acetate (Drug)
Long protocol-leuprolide acetate
Long GnRH agonist protocol Luteal Phase Support: Vaginal progesterone+oral estradiol valerate subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
干预措施: Leuprolide acetate (Drug)
Long protocol-leuprolide acetate
Long GnRH agonist protocol Luteal Phase Support: Vaginal progesterone+oral estradiol valerate subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
干预措施: vaginal progesterone (Drug)
Long protocol-leuprolide acetate
Long GnRH agonist protocol Luteal Phase Support: Vaginal progesterone+oral estradiol valerate subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
干预措施: 4 mg oral estradiol valerate (Drug)
GnRHantagonist protocol(control group)
GnRH antagonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate
干预措施: vaginal progesterone (Drug)
GnRHantagonist protocol(control group)
GnRH antagonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate
干预措施: 4 mg oral estradiol valerate (Drug)
antagonist protocol-leuprolide acetate
GnRH antagonist protocol Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate + subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
干预措施: vaginal progesterone (Drug)
antagonist protocol-leuprolide acetate
GnRH antagonist protocol Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate + subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
干预措施: 4 mg oral estradiol valerate (Drug)
结局指标
主要结局
Live Birth Rate
时间窗: 42 weeks
次要结局
- Ongoing pregnancy(more than 20 weeks)
- miscarriage(up to 20 weeks)
- OHSS(up to 10 weeks)
研究者
Nagihan CENGAVER
Resident
Zekai Tahir Burak Women's Health Research and Education Hospital