Table 4:
Examples of clinical data elements for an MDS Infertility Monitoring System
| Part | Data elements | ||
|---|---|---|---|
| Causes of infertility | Tubular factor (missing, obstructed or fallopian tubes in a freshly inoculated cycle), ovulation impairment (defective ovulation release) in the freshly non-hereditary cycle, infertility due to reduced ovarian reserve, endometriosis, uterine factors (uterine abnormalities), menopause, ovarian failure, unknown factors, various factors related to women, factors related to both men and women, male factors (azoospermia, oligospermia, teratozoospermia), other factors. | ||
| Medical history | Sexual History | Menstrual history | Age of first period, date of the last period, features and cycle length, any pre-menstrual symptoms (PMS) (bloating, breast tenderness, mood change), bleeding or spotting between periods, pattern of the menstrual cycle (regular/irregular/spotting before period, light flow/heavy flow, bleeding between cycles, no period), menstrual days, changes in the menstruation over the past two years, painful menstruation, severity of cramps, medications for reduce pain, Last Monthly period/ LMP(last menstrual period)/Previous Menstrual Period, early menopause, postmenopausal bleeding, other. |
| Sexual History | discomfort with intercourse, dyspareunia (painful intercourse), use of lubricants, discharge, number (repetition) of intercourse per week/month, intercourse for ovulation, douche before or immediately after intercourse, postcoital bleeding, leaving bed after intercourse, problems with initiating or completing intercourse,plan intercourse for a specific time of cycle, ejaculation problem, erection problems, spermatic ejaculation into the bladder, secretion or penile pain, recent changes in sexual stimulation, Undescended testicles, scrotal or testicular pain, testicular damage requiring hospitalization, the average number of ejaculations per week, Age of first of shaving regularly, sexual satisfaction, sexual relation status, follow-up due to infection or sexually transmitted diseases (Chlamydia, Gonorrhea, Herpes, genital warts, Syphilis, AIDS, hepatitis), other. | ||
| previous examinations | infection/ irritation of pelvic organs, yeast infection, bladder infection (UTI), pelvic inflammatory disease (PID), polycystic ovary syndrome (PCOS), Endometrial Polyp(s),Ovarian Cyst(s), Endometriosis, Strep B, Herpes, Syphilis, HPV, genital warts, Gonorrhea, Chlamydia, Crabs, Trichomonas, Vaginitis, bacterial vaginosis, past semen analyses, prostate infection, penile infection, impotence, varicocele, gastroesophageal reflux disease, the time length to get pregnant now, the length of time when the contraceptive method is not used, Prior Testing: Post Coital Test (PCT), Endometrial Biopsy (EMB), Hysterosalpingogram (HSG), Endometrial biopsy, Sonohysterogram, Laparoscopy, Hysteroscopy, Thyroid tests, Chromosomes, Genetic Screening, Prolactin (PRL), hamster ovarian testing, hormonal assay (FSH, LH, prolactin, testosterone, progesterone, estrogen, DHEA-S)/ blood tests, Estradiol (E2), follicular ultrasound count, Clomid Challenge Test, PAP smear, abnormal PAP Smear, last mammogram, Semen Analysis, Allergies (Allergic to, Reaction), other | ||
| Previous Treatment | Type and Date of Treatment, treatment outcome, antibiotics, clomiphene citrate with scheduled intercourse, clomiphene citrate with intrauterine insemination (IUI), clomiphene citrate with metformin, daily injection of IUI fertility, insulin sensitivity, Clomiphene citrate (Serophene, Clomid), hMG (Pergonal), danazol (Danocrine), Prednisone, Bromocriptine (Parlodel), Progesterone, Antibiotic, hCG (Profasi, Estrogens, urofollitropin or FSH (Metrodin), GnRH (Depo-Lupron), Daily fertility injections/gonadotropins (Gonal-F, Follistim, Menopur, Bravelle), Urofollitropin or FSH (Follistim, Metrodino), Gonal-Aff-Folium)/Hmg (O, Metrodino), / hCG (Profasi, Pregnyl)/ hCG(ProfessiONAL.P.LO), IVF, GIFT,ZIFT, other | ||
| Prior Surgeries | Date, Procedure, Reason, type of surgery, surgery to open the fallopian tubes, surgery to remove adhesions, conjunctiva or cervical cavity, dilation and durettage (D&C) for abortion, for abortion after childbirth or for abnormal bleeding, any other surgery (ovarian, appendectomy, thyroid), bladder surgery during childhood, fallopian tube surgery, removal of the uterus, removal of the ovaries, surgery for sterilization/varicocele, bladder or penis surgery as child, vasectomy, vasectomy reversal, other | ||
| Infertility Treatment History (Prior IVF / ICSI cycles / or previous frozen embryos transfer) | Dates, medications used and their total dosage, Peak estradiol, prior Clomiphene citrate (Serophene,Clomid) cycles, prior Letrozole (Femara) cycles, prior Gonadotropin cycles (Gonal-F, Follistim, Menopur, Repronex, Bravelle), Number of prior Fresh/ Frozen IVF cycles, Number of ovarian, adult ovarian, number of fertilized oocytes (2PN), ICSI, the number of embryos transferred, frozen embryos, embryos stages, outcome (pregnancy, delivery). | ||
| Disease History | Height, weight, maximum weight, minimum weight of adulthood, unexplained weight loss, loss of more than 20 pounds in weight in the last year, excessive hair loss, eating disorders, Cryptorchidism, Cystic Fibrosis, cystitis, elevated Testosterone, Endocrine Problem, Endometriosis, Female Reproductive Problems, Galactoreaonorrhea, infertility factors, PCOS, tubal problems, Pelvic infection (PID), nipple discharge, Gonorrhea, Syphilis, Chlamydia, delayed puberty, diabetes, HIV/AHDS, Hepatitis, history of Mumps, difficulty with erection/ejaculation, retrograde ejaculation of sperm into the bladder, history of undescended testes, any serious genital injuries, any infection of the penis/testicle/prostate gland, hernia repair, contraceptive practices (IUD, birth control pills, tubal sterilization, injectable contraception), other | ||
| Medication History | Drug, indication, dosage, Frequency, Duration, date, Anabolic steroids, Bravelle Estrogen Patch, Climara Estrogen Patch, Clomid (Serophene), Gonal F, Esrtodial, Follistim, Ganirelix, Lovenox, Pergonal, hCG Profasi, Repronex, herbal remedies or natural remedies, antibiotics, cortisone or steroids, Heparin, Antagon, Parlodel, baby Asprin, blood pressure pills, thyroid/ heart / urological drugs, sedative pills or nerves, Appetite suppressors or pep tablets, hormonal pills or shots, contraceptive practices (Birth control Pills), other. | ||
| Social History | Alcohol/cocoa/caffeine drinking, cigarette smoking, recreational drugs usage (marijuana, heroin, cocaine), dietary supplements, herbal or sports supplements, exposure to (chemicals, X-rays, heat, steroids, cancer drugs, Lead, Poisons), exercise regularly, other. | ||
| Family History | Any disease in the family, Cancer (Breast, Ovarian), infertility, Endometriosis, Cystic Fibrosis, fibroids, thyroid problems, infertility problems, history of recurring miscarriages, PCOS, pregnancy difficulties, anemia, autoimmune disorders such as lupus or rheumatoid arthritis, any birth defects, birth defects require surgery (cleft palate, lips), any inherited disorders, bleeding disorders (hemophilia, and others), other illness. | ||
| Pregnancy History | Pregnancy length, total pregnancies, duration of pregnancy (weeks, miscarriage, full-term), number of full term deliveries, Method of Delivery (Vaginal, C-section), full-term (>37 weeks) birth, pre-term(<37 weeks) birth, biochemical pregnancies, the number of previous births (sex, weight), therapeutic (elective) abortions, spontaneous loss (miscarriages), number of ectopic/ tubal pregnancies, live birth, multiple birth, stillbirth, any pregnancies with birth defects, number of preterm deliveries (less than 37 weeks, preeclampsia/eclampsia, heavy bleeding, infertility treatment | ||
| Tests | Andrology Tests in men | Semen analysis alone (sperm count, volume, motility, morphology), semen analysis and sperm DNA splitting test, repeat DNA division test (in 4 weeks after the initial test), semen analysis and ART appropriateness, IUI preparation for infertility into the uterus, donor preparation, sperm analysis with anti-sperm antibody testing, retrograde ejaculation analysis, spontaneous ejaculation analysis, semen/sperm freezing, post-vasectomy check, semen culture, FSH, Total Testosterone, Y microdeletion, Albumin, Prolactin, TSH, Free T4, Bioavailable Testosterone, Peripheral Blood karyotype, SHGB, Universal Plus, other. | |
| Immunological examination in women | Screening for Cystic Fibrosis, Rubella & Varicella (Chicken Pox) immunity. Clomiphene citrate (Clomid) challenge test (CCCT), Ovarian Assessment Report (OAR) through Reprosource, Progesterone (P4), Anti-phospholipid antibodies (APA or ACA), lupus anticoagulant (LAC), glycoprotein I Anti-ß2, anti-microsomal antibodies (AMA), antithyroglobulin antibodies (ATG), thyroid-stimulating hormone antibodies, HLA DQ, Glucose, DHEAS, 17 OHP, Prolactin, Testosterone, TSH, Free T4, LH, Hemoglobin A1C, Universal Plus, Fragile X, Uterine/Tubal Evaluation, HSG, SSG, other. | ||
| Treatment plan | Features of the cycle | Type of cycle associated with: oocytes, newly non-donated, newly donated, shared cycle, non-donated melting cycle, donation melting cycle, fresh cycle receptor, initiated cycles, Treatment code, cycle code, number of freeze-melted cycles in IVF and ICSI, start date of the cycle, other | |
| specifications of eggs, Embryos / blastocyst profile, treatments | Types of ART cycles or fertilization methods: in vitro fertilization (IVF), fertility treatment intracytoplasmic sperm injection (ICSI), gamete intrafallopian transfer (GIFT), frozen embryo transfer (FET), ovulation maturation, Pre-implantation genetic diagnosis (PGD), pre-implantation genetic screening (PGS), Surrogacy, with fresh ovulations, fresh donation of oocyte, new donation, embryo transfer, freeze transfer), IUI, IVF/ICSI, stimulant drugs: 1-GnRH agonist, GnRH antagonist, clomiphene citrate, hMG / FSH, LH, other, none, Ovum source: donated, non-donated, hot/ melted/warm, fresh donated, Sperm source: 1-partner/donation, 2-Non-donated ejaculation, 3- lack of non-donated ejaculation 4- Freezing, other. | ||
| Treatment results | Treatment results: Pregnancy and childbirth | Lack of follow up (pregnancy), transmission cycles, clinical pregnancy, clinical pregnancy per culture, missed pregnancy, completion date of pregnancy, live intrauterine pregnancy at week 7 or later, other. | |
| Complicationss | Complications (yes/no) 1- OHSS (high ovarian stimulation syndrome) 2. Pelvic infections requiring admission 3. Thrombosis 4. Bleeding 5. Complications of ovulation recovery 6. Other serious complications 7. Mother’s death, Associated medical disorders, chronic infections (hepatitis B, C, HIV), hospitalization due to complications, admission to assisted reproductive technology (ART), other. | ||
| Donor information | Donor information | First name, last name, date of birth, height, body mass index, and eye color, blood type, other. | |