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临床试验/CTRI/2022/09/045889
CTRI/2022/09/045889招募中未知

Genetic profiling of women with infertility requiring assisted reproduction

Strand Life Sciences Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
招募中

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 1. Consenting female subjects aged between 21-35 years
  • 2. Couples who have been trying to conceive for at least 1 year
  • 3. Clinical diagnosis of unexplained infertility
  • 4. Patients who have not conceived with 3 ART cycles (IUI or IVF) with donor gametes, if
  • partner is diagnosed with male factor infertility
  • 5. Normal uterine cavity as visualised by 3-D ultrasound or hysteroscopy
  • 6. At least one patent fallopian tube as evaluated by sonosalpingography or
  • hysterosalpingography or laparoscopy

排除标准

  • 1. Body mass index (BMI) =30 kg/m2
  • 2. History of known structural anomalies of the uterus or cervical stenosis as established by
  • clinical examination and diagnostic procedures such as hysteroscopy or laparoscopy or
  • 3. History of ovarian factor infertility as established by a diagnosis of PCOS, ovarian cysts
  • or tumours on ultrasound
  • 4. Clinical history of irregular menstrual cycles or amenorrhea
  • 5. History suggestive of poor ovarian reserve with an antral follicle count (AFC) of =5 on
  • day 2 or Anti-Mullerian Hormone levels (AMH) of <1.2 ng/mL at the time of diagnosis
  • at initial clinical presentation
  • 6. History suggestive of uncontrolled thyroid disorder, uncontrolled diabetes mellitus or
  • hyperprolactinemia or clinically significant changes in hormones that may be associated
  • with infertility
  • 7. Any abnormalities detected on ultrasound or hysterosalpingography or laparoscopy or
  • hysteroscopy that may be associated with infertility
  • 8. Any prior medical or surgical treatments in female partner that may be associated with
  • infertility
  • 9. History or lab investigations suggesting presence of STIs (HIV1/2, HBsAg, HCV)
  • 10. Clinical history of infectious disease or autoimmune disease known to cause infertility
  • eg. Genital Tuberculosis, SLE
  • 11. History of any known chromosomal defects or genetic disorders in the subject
  • 12. History of any pregnancy in the past in subjects
  • 13. History of recurrent pregnancy loss or miscarriages in the subject
  • 14. History of male factor infertility, if the couple has not tried at least 3 cycles of ART (IUI
  • or IVF) with donor sperms
  • 15. Any psychosexual causes in the couple which may result in a failure to conceive, if the couple has not undergone an assisted reproductive technology (IUI and IVF) based

研究者

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