Does rTMS Repetitive transcranial magnetic stimulation improve the outcome of in vitro fertilization in infertile women with moderate to severe depression
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of rTMS on the clinical pregnancy rate in infertile women with depression undergoing IVF-Fresh ET
研究概览
简要总结
This study is a pilot randomized, parallel group, placebo controlled trial studying the effect of rTMS (Repetitive transcranial magnetic stimulation) on the reproductive outcome in 40 infertile women with moderate to severe depression undergoing IVF cycles at ART centre, Department of Obstetrics and Gynaecology. The primary outcome measures the effect of rTMS on the clinical pregnancy rate in infertile women with depression undergoing IVF-Fresh ET cycles at 8 weeks. The secondary outcomes will be to assess depression measured using HAM-D questionnaire at 3 weeks, serum cortisol and BDNF levels at 3 weeks, oocyte and embryo quality at 6 weeks and implantation success by measuring Beta HCG level at 7 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women undergoing IVF at ART center & willing to participate
- •Moderate to severe depression.
排除标准
- •Comorbid psychiatric illness Substance abuse including nicotine Any other contraindication for rTMS Women with moderate to severe depression opting for pharmacotherapy Donor Recipient cycles Severe OATS (Oligoasthenoteratozoospermia) Oncofertility Hyper-responders like PCOS undergoing segmented Embryo Transfer.
结局指标
主要结局
Effect of rTMS on the clinical pregnancy rate in infertile women with depression undergoing IVF-Fresh ET
时间窗: 8 weeks
次要结局
- To assess depression measured using HAM-D questionnaire pre and post rTMS(3 weeks)
- To assess the biochemical levels (Cortisol, BDNF) pre and post rTMS(3 weeks)
- Oocyte and Embryo quality(6 weeks)
- Implantation success by measuring Beta HCG levels(7 weeks)
研究者
Dr Kataru Nikitha
AIIMS, New Delhi