Objective SARS-CoV-2 has led to a rapidly spreading COVID-19 global pandemic. Since the putative receptor for the virus is identified in reproductive organs, it is important to examine if SARS-CoV-2 targets the human reproductive tract. And, if so, is COVID-19 a sexually transmitted disease (STD)? Evidence Review A systematic review of English publications to December 11, 2020, was conducted in PubMed, NIH iCite COVID-19 portfolio, Cochrane Library, and Google Scholar databases, searching for SARS-CoV-2 in testes, seminal, prostatic and vaginal fluids, and in cervical smears. 1,997 records were identified, duplicates were removed, and 1,490 records were reviewed for eligibility by examining titles and abstracts. 202 full-text relevant articles were reviewed by two independent reviewers. 47studies (literature reviews, editorials, and guidelines) were assessed qualitatively and 23 studies that tested the male and female reproductive tracts of COVID-19 patients for SARS-CoV-2 were quantitatively analyzed. Findings No epidemiological investigations to date have described evidence suggesting that COVID-19 is an STD. While ACE2 receptor is found in reproductive organs, the lack of co-expression of the TMPRSS2 modulatory protein, required for SARS-CoV-2 cell entry, in testicular cells, sperm, or oocytes, argues against the hypothesis that gametes transmit SARS-CoV-2. Molecular detection studies of SARS-CoV-2 RNA in the male and female reproductive tracts were summarized: 98.0% (293/299) of the seminal fluids, 16/17 testicular biopsies, all 89 prostatic fluids, 98.3% (57/58) of the vaginal fluids, all 35 cervical smears, and all 16 oocyte samples tested negative for SARS-CoV-2. None of the studies confirmed sexual transmission of SARS-CoV-2. Nonetheless, COVID-19 may have detrimental effects on male reproduction by inducing orchitis and/or decreasing testosterone levels, sperm counts, and motility. Conclusions Based on the current worldwide published information, COVID-19 is not an STD. This information is important for clinicians, proposed guidelines for public health, FDA guidelines for gamete and tissue donor eligibility, and for fertility treatments. Universal precautions, currently practiced worldwide, are adequate and sufficient at this time to prevent the transmission of known or unknown viral infections. We suggest that recovered patients of COVID-19, especially those with infertility, should be evaluated for their ovarian and testicular function.

OBJECTIVE: To assess the efficacy and safety of LGX, an oral GnRH receptor antagonist, administered with and without hormonal add-back therapy (ABT: 1 mg estradiol/0.5 mg norethindrone acetate), for the treatment of HMB and other symptoms of UF.DESIGN: PRIMROSE 1 (USA, n¼526) and PRIMROSE 2 (Europe and USA, n¼511) are randomized, double-blind, placebo-controlled Phase 3 trials, with essentially identical design, investigating the efficacy and safety of LGX AE ABT once daily for 52 weeks. We report results up to 24-weeks for PRIMROSE 1 and up to 52-weeks for PRIM-ROSE 2.MATERIALS AND METHODS: Participants had HMB (> 80 mL menstrual blood loss [MBL]/cycle) due to UF and excluded if they had significant risk of osteoporosis. Subjects were randomized to 1 of 5 treatments: placebo, LGX 100 mg, LGX 100 mg + ABT, LGX 200 mg, LGX 200 mg + ABT. PRIMROSE 2 subjects randomized to placebo or LGX 200 mg were crossed-over to 200 mg LGX + ABT after 24 weeks.The primary efficacy endpoint was reduction in alkaline-hematin documented HMB to % 80 mL MBL and a reduction of R 50% at 24 weeks. Secondary endpoints included amenorrhea, time to reduced MBL/amenorrhea, days of uterine bleeding, hemoglobin, pain, uterine and fibroid volume and quality of life. Safety endpoints included bone mineral density (BMD) assessed centrally using Dual Energy X-ray Absorptiometry and adverse events (AE). Calcium/vitamin D were not provided nor recommended in the trials.Individual active vs placebo efficacy comparisons were conducted using a 0.0125 significance level to account for multiplicity.RESULTS: PRIMROSE 1 subjects had a mean age of 42 years and 63% were Black. The mean baseline MBL was 199 mL. HMB at week 24 was significantly (p%0.003) reduced in all active treatment groups compared to placebo. Responder rates were 35, 56, 67, 71 and 75% in the placebo, 100 mg, 100 mg + ABT, 200 mg and 200 mg + ABT groups, respectively.PRIMROSE 2 subjects had a mean age of 43 years and 5% were Black. The mean baseline MBL was 218 mL. HMB at week 24 was significantly (p<0.001) reduced in all active treatment groups compared to placebo. Responder rates were 29, 57, 77, 78 and 94% in the respective groups, and were maintained at 52 weeks.In both trials, significant improvements compared to placebo were observed for key secondary endpoints, including pain and QoL, at week 24. Mean % loss in BMD ranged from 0-2% after 24 weeks in all active treatment groups except 200 mg LGX without ABT (3-4%). The rate of BMD loss slowed between weeks 24 and 52. The most common AE, hot flushes, were reported in 32-35% of subjects in the LGX 200 mg without ABT group and less than 15% in the other active treatment groups at week 24.CONCLUSIONS: Once daily LGX 100 and 200 mg, both with or without ABT significantly improved HMB and other symptoms of uterine fibroids at 24 weeks and these improvements were maintained at 52 weeks. An effective GnRH antagonist treatment without hormonal ABT could be important for up to 50% of patients who may have contraindications to hormonal ABT. Limi...