Abstract:
Objectives: Infertility is a major public health problem globally, including India; the etiopathogenesis of reproductive disorders amongst ethnically disparate populations is indeed complex. Cost-effective, evidence-based intervention strategies are essential for infertility control/prevention. My pilot study aimed to assess the in vitro fertilization success trends and neonatal developmental defects/neonatal deaths amongst Mycobacterium tuberculi and Human Papillomavirus positive infertile women of Asian-Indian ethnicity.
Methods: A prospective clinical research study enrolling 1380 infertile women undergoing Assisted-Reproductive-Technology procedures at Indira-IVF Hospital, Udaipur, India was rigorously conducted; inclusion criteria: age<35 years, Indian ethnicity, Body Mass Index (kg/m2)<25, Anti-Mullerian Hormone (AMH)1.5-2.5 ng/ml, and exclusion criteria: prior ≥2 IVF failures, fibroids, adenomyosis, cervical cancer, thin endometrium, endometriosis. IVF success was determined by assessing total frozen embryos transferred per month, average oocyte yield per donor, oocyte quality, and pregnancy/beta-Human Chorionic Gonadotrophin (HCG) positivity. M. tb.-positivity was assessed using Gene-Expert/TB-Gold-PCR-testing and endometrial thickness using Color-Doppler-imaging. HPV-positivity was evaluated using FDA-approved hybrid capture (hc)-2 assay. Psycho-sexual interventions incorporated marital-relationship counseling-sessions/therapy, clinical referrals for neuropsychiatric assessments (cognitive impairment/schizophrenia/depression). Written informed consent of patients was taken at initial enrollment.
Results and Conclusions: Total embryos transferred were 248/April, 240/May, 201/June, 254/July, 230/August, 207/September; number of pregnancies/β-hCG positivity: 171,171, 139, 179, 176, 163. Subgroup-stratification demonstrated that M-II vs total oocytes retrieved were 72.7%, 66.6%, 83.1%, 73.0%, 72.1% and 74.2%. Overall IVF success rates were 71%/April, 72%/May, 71%/June, 72%/July, 78%/August and 84%/September, and frozen embryo-transfer success was 68%, 75%, 74%, 85%, 77%, 83%. M. tb. (55.6%), HPV-positivity (12.0%) and self-reported tobacco-usage (100% response rate) were significantly associated with aberrant fetal cardiac activity, higher trends of intrauterine growth restriction and neonatal deaths (P<0.05). My maternal-fetal-neonatology innovative study highlights promising IVF success rates in Asian-Indian infertile women; future public health research, awareness-campaigns, psychosocial interventions and pharmacogenetic/genomics epidemiological causal association studies are warranted for successful development of predictive biomarkers for infertility management in ethnically disparate populations, and identifying aberrant microbiome at the maternal-fetal interface tilting the “embryonic/fetal fate” towards still-births and/or autophagy-mediated neonatal cell death.