Conventional Infertility Treatment vs. Fast Track to IVF (FASTT)
Infertility
About this trial
This is an interventional treatment trial for Infertility focused on measuring Infertility, Advanced maternal age, Pregnancy, Reproductive health, Fertility treatment, Reproduction
Eligibility Criteria
Inclusion Criteria: Female partner age 21 up to 40th birthday, at the time of recruitment. Infertility is defined as failure to conceive a recognized pregnancy after one year (or 12 menstrual cycles) of unprotected intercourse. Male partner has a normal semen analysis with a sperm concentration of >15 million total motile sperm, >1% normal forms by strict criteria, or >5 million total motile sperm on IUI prep. Female patient has at least one ovary and at least one ipsilateral patent fallopian tube confirmed by HSG or laparoscopy; pelvic pathology amenable to operative laparoscopy (pelvis restored to functional). The open tube cannot have had a previous ectopic (tubal) pregnancy and the closed tube cannot be a hydrosalpinx (a tube that is blocked at the end and filled with fluid), unless a tubal ligation has been performed at the junction of the uterus and fallopian tube. Patients with surgically corrected stages I and II endometriosis will be included. Normal uterine cavity demonstrated by HSG, Sonohysterogram (SHG), or hysteroscopy; pathologies of uterine cavity amenable to operative hysteroscopy (cavity restored to normal and demonstrated by post operative study). Anovulatory patients who did not conceive after a minimum of three ovulatory cycles with any medications, not including gonadotropin therapy. Anovulatory patients unable to achieve ovulation at dosages up to 150 mg of clomiphene or standard dosages of other ovulation inducing medications (i.e. bromocriptine). Hypoestrogenic hypothalamic amenorrhea patients will qualify immediately for inclusion, prior to any gonadotropin therapy. Normal ovarian reserve demonstrated in all patients i.e., cycle day 3 FSH/E2 values of <15 mIU/mL and <100 pg/mL, respectively. Normal TSH and prolactin. Female body mass index ≤ 38. Exclusion Criteria: Previous tubal reconstructive surgery in which the pelvis was not restored to functional. Unilateral or bilateral hydrosalpinx (a tube that is blocked at the end and filled with fluid) that has not had a tubal ligation performed at the junction of the uterus and fallopian tubes. A laparoscopy that demonstrated pelvic adhesions or endometriosis for which the pelvis could not be restored to normal by surgery or endometriosis was not ablated or excised. All patients with stages III and IV endometriosis. One or more prior ectopic pregnancies in which one or both tubes were rendered nonfunctional; two or more ectopic pregnancies, even if tubes are patent. Severe male factor (i.e.; semen analysis with a sperm concentration of <15 million total motile sperm, <1% normal forms by strict criteria, or <5 million total motile sperm on IUI prep). Couples using donor semen will be excluded. Previous treatment with IUI or IVF. Previous treatment of normal ovulation patients with gonadotropins. Inadequate ovarian reserve demonstrating FSH >15 mIU/mL or estradiol > 100 pg/mL. Patients requiring gamete intrafallopian tube transfer (GIFT), zygote intrafallopian tube transfer (ZIFT), or tubal embryo transfer (TET). Female body mass index > 38.
Sites / Locations
- Harvard Vanguard Medical Associates
- Boston IVf
- Harvard Vanguard Medical Associates
- Boston IVF
- Harvard Vanguard Medical Associates
- Boston IVF
- Harvard Vanguard Medical Associates
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
I.
II.
Conventional infertility therapy
Fast track to in vitro fertilization therapy