Health Condition 1: N978- Female infertility of other origin
Conditions
Interventions
Intervention1: autologous bone marrow-derived stem cell intra-ovarian instillation: autologous bone marrow derived stem cell intra-ovarian instillation will be done.
Intervention2: autologous platelet
Sponsors
VMMC and Safdarjung Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: Exclusion criteria: · Refusal /Inability to give informed consent · Any illness that precludes the use of anesthesia · Sonographically unapproachable ovaries. · 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. · 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. · 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antral Follicle Count Timepoint: Baseline,3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in menstrual pattern Timepoint: 3 months;Change in Serum AMH & FSH levelTimepoint: Baseline,3 months;Number of MII oocytes retrieved, Fertilisation rate, Blastocyst formation rate Timepoint: First ovarian stimulation cycle after the 3-month assessment, at the earliest feasible opportunity within 6 months post-intervention.;Change in the level of IL-6,TGF-beta,VEGF,IGF-1,Inhibin B,PDGF Timepoint: Baseline,3 months | — |
Countries
India
Contacts
Public ContactDr Divya Pandey
Vardhman Mahavir Medical College and SafdarJung hsptl
Outcome results
None listed