Autologous Stem Cell Ovarian RejuvEnation (A-SCORE) Therapy for Infertile women with Poor Ovarian Reserve: an open-label prospective clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Antral Follicle Count
研究概览
简要总结
The management and treatment of women with poor ovarian reserve (POR) is a challenging clinical situation with prevalence estimated to be between 9 and 24%. Importantly, egg quantity and quality seem to be compromised in this POR population. The aged oocytes tend to give rise to errors in cell division, leading to higher rates of aneuploidy and congenital malformations. The remedy to resultant infertility is either in-vitro fertilization (IVF) treatment with donor oocyte or adoption.
Off-late attempts to rejuvenate ovarian function are being made and are under investigation to avoid these events. The use of Autologous Bone Marrow-derived Mononuclear Stem Cells (ABMMSC) is one such modality, which might prove promising in these cases. Bone marrow-derived mononuclear cells (MNCs) form a promising option of cell therapy for regenerative medicine because they can be rapidly isolated from patients after a bone marrow aspiration, do not require culture, and therefore permit autologous applications.Autologous platelet-rich plasma is another modality in this regard.
The available data on efficacy is mainly available from some preclinical studies and a few observational clinical studies.
With this background, this study is being proposed to explore the efficacy of autologous bone marrow-derived stem cells for the rejuvenation of ovaries in females with POR in terms of restoration of ovarian function by improved folliculogenesis, steroidogenesis, menstrual function, and fertility status.
This might provide a potential treatment option for infertile females with poor ovarian reserve (POR) by providing them with an opportunity for improvement in hormonal profile, symptomatic relief in menstrual symptoms and above all possibility to have their biological offspring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Infertile women with Serum AMH (Anti Mullerian Hormone less than 1.2ng per ml (in the absence of oral contraceptive and sex steroid intake) AFC (Antral Follicle Count) less than 5 (in the absence of oral contraceptive and sex steroid intake) POSEIDON group 3 and 4(Expected poor responders) Hb more than 11 gm percent and platelets more than 1.5 lakhs normal karyotype presence of at least one ovary normal thyroid function and prolactin Normal Body Mass Index (18.5 to 24.9 kg per metre square Normal serum Vitamin D and B12 level.
排除标准
- •Exclusion criteria: · Refusal /Inability to give informed consent · Any illness that precludes the use of anesthesia · Sonographically unapproachable ovaries.
- •Â· POSEIDON 1 and 2 group (unexpected poor responders) · Post chemotherapy or radiotherapy · Any genetic or chromosomal disorder/abnormal karyotype · Pregnant/breastfeeding women · history of previous ovarian surgery, · known clinical/biochemical hyperandrogenism or PCOS.
- •Â· History of autoimmune disorder · history of symptoms of platelet dysfunction such as easy bruisability, frequent nose-bleeds, heavy menstrual bleeding, bleeding gums or excessive bleeding during dental procedures, bleeding disorder, · blood-borne diseases like Hepatitis B, Hepatitis C, Syphilis, HIV, · History of or evidence of any gynecologic malignancy, · medical co-morbidity like heart disease, renal, pulmonary, liver, cerebrovascular disease, Diabetes mellitus, anemia, Deep venous thrombosis, coagulation disorder etc.
- •Â· History of current or recent drug intake (within last 12 weeks) (steroids, estrogens, progesterone, oral contraceptive pill, anticoagulant, NSAIDS, any other supplement with possible hormonal effect, · Mullerian abnormality or any anatomical uterine disorder, · Ashermann Syndrome, · Endometriosis, · active vaginal/cervix infection, any significant co-morbidity/ psychiatric disorder which compromises or interferes with consent giving/study participation/ follow up or interpretation of study.
结局指标
主要结局
Antral Follicle Count
时间窗: Baseline,12 weeks
Serum AMH level (Anti Mullerian Hormone) (ng/ml)
时间窗: Baseline,12 weeks
Serum FSH level (Follicle stimulating hormone) (mIU /ml)
时间窗: Baseline,12 weeks
次要结局
- Change in menstrual pattern
- Number of MII oocytes retrieved, Fertilisation rate,(Blastocyst formation rate)
- Change in the level of IL-6,IL-11,TGF-beta,VEGF,IGF-1
研究者
Dr Divya Pandey
Vardhman Mahavir Medical College and SafdarJung hsptl