A Randomized Controlled Trial to assess the clinical outcomes with different durations of Transdermal Testosterone gel as pretreatment in patients with Poor prognosis in Antagonist IVF/ICSI cycles
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- CLINICAL PREGNANCY RATE
研究概览
简要总结
Allinfertility patients will undergo detailedHistory & examination complete hematological , biochemical& ultrasound screening will be done
AFC isascertained 5 ml bloodsample is sent for Complete blood count, Serum AMH, Blood sugar, Urine-routine& microscopy, TSH, Prolactin, HIV, HbsAg, VDRL and Anti-HCV
to look forinclusion and exclusion criteria
After ethicalclearance and proper informed consent patients who fulfil the inclusioncriteria will be enrolled into one of the 4 groups randomly by a computergenerated randomization program
TVS monitoringwould be started on day 2 of menses
Controlledovarian hyperstimulation with Antagonist protocol followed by either IVF /ICSI atAkanksha IVF Center
Oocyteretrievals will be performed under transvaginal ultrasound guidance 35 - 36hours after HCG trigger
Fresh embryotransfers will be performed for all cases ,soft catheterwill be used for embryo transfer . Transfers& ultrasounds will be done by a single clinician to avoid bias
All embryoswill be graded according to Istanbul Consensus 2011
The lutealphase support with vaginal micronized progesterone
Urinepregnancy test will be performed after 14 days of embryo transfer, if positiveluteal support will be given until 12th week of pregnancy
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 39.00 Year(s)（—）
- 性别
- Female
入选标准
- •antral follicle count less than 5 anti mullerian hormone less than/ equal to 1.1ng/ml.
排除标准
- 未提供
结局指标
主要结局
CLINICAL PREGNANCY RATE
时间窗: CARDIAC ACTIVITY AT 7WEEKS after last menstrual period
次要结局
- No. of mature oocytes(miscarriage rates)