CTRI/2017/09/009934尚未招募1 期
Phase I â??II Clinical Trial on Safety, Immunogenicity and probing efficacy of the Revived Recombinant Vaccine against Human Chorionic Gonadotropin (hCG) - R-βhCG
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Willing to participate in the trial and sign the consent form and audio visual recording.
- •2.Healthy married sexually active women (age group 22-35) who have completed their family with minimum two living children.
- •3.Has ovulatory cycles
- •4. Menstruating regularly
- •5.Not using any hormonal contraceptive since the last 6 months
- •6.Using non-hormonal IUDs or willing to use non-hormonal IUDs or who have already undergone sterilization.
- •7.Women after six months of delivery with regular menstrual cycles or six weeks after Medical Termination of Pregnancy (MTP) with return of regular menstrual cycle.
- •8.Resident of Delhi/NCR
排除标准
- •1.Women who are pregnant or suspecting pregnancy
- •2.who are currently breast feeding
- •3.women having â??
- •i)STD, Reproductive Tract Infection (RTI) and HIV, HCV, Hepatitis B, VDRL, HBsAg infection,
- •ii)Gynaecological disorders
- •iii)history of recurrent abortion
- •iv)history of Joint pains
- •v)secondary infertility
- •vi)any type of suspected cancer
- •vii)allergic to any drug or food, auto-immune and endocrine disorders
- •viii)known systematic disease and on chronic drug therapy i.e. hormone therapy
- •ix)any psychiatric disorders
- •x)BMI above 30, (obese)
- •xi)PCOS (using Rotterdam Criteria)
- •xii) any problem with IUDs
- •4.who are currently using any other hormonal contraceptive
研究者
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