Clomiphene Citrate co-treatment with low dose urinary FSH versus urinary FSH for clomiphene resistant PCOS: randomized c

  • PDF / 280,359 Bytes
  • 9 Pages / 595.276 x 790.866 pts Page_size
  • 98 Downloads / 197 Views

DOWNLOAD

REPORT


ASSISTED REPRODUCTION TECHNOLOGIES

Clomiphene Citrate co-treatment with low dose urinary FSH versus urinary FSH for clomiphene resistant PCOS: randomized controlled trial Mohamad E. Ghanem & Laila A. Elboghdady & Mohamad Hassan & Adel S. Helal & Ahmed Gibreel & Maha Houssen & Mohamed E. Shaker & Ibrahiem Bahlol & Yaser Mesbah

Received: 29 June 2013 / Accepted: 19 August 2013 / Published online: 7 September 2013 # Springer Science+Business Media New York 2013

Abstract Purpose The aim of this study was to examine the effect of clomiphene citrate [CC] co-administration during the use of exogenous low-dose urinary FSH [uFSH] for induction of ovulation in CC-resistant infertile PCOS women. Methods In a randomised controlled setting, 174 CC-resistant infertile PCOS women were randomized into two parallel groups; Group I received CC 100 mg/day for 5 days plus uFSH 37.5 IU/ day while group II received only uFSH 37.5 IU /day. Subsequent increments of uFSH by 37.5 IU/day were made according to response. Primary outcome was ovulation rate. Secondary outcomes were clinical pregnancy rates, number of follicles, endometrial thickness, and gonadotropins consumption. Results Our results have demonstrated that group I compared to group II had significantly higher ovulation rate per intention to treat [ITT] [72.4 % vs. 34.2 %, p 8]}; and transvaginal ultrasound (TVS) for ovarian pattern and volume. For each patient, fasting blood glucose and insulin were measured, to determine insulin resistance, fasting triglycerides, high density lipoprotein (HDL), free testosterone, and basal FSH and LH were assayed. On the day of human chorionic gonadotropin (hCG) injection, serum samples were collected for measurement of serum E2 and FSH. Starting from the 3rd day of the cycle (spontaneous or progesterone withdrawal), group I received CC oral tablets (Clomid, 50 mg tablets Global Napy Pharmaceuticals 2nd Industrial zone 6th October City, Egypt) in 100 mg daily doses for 5 days plus intramuscular (IM) injection of 37.5 IU/day HP uFSH (Fostimone, IBSA CH 6903 Lugano, Switzerland) from the 3rd to the 13th cycle day. Group II was given highly purified (HP uFSH) only in the same daily doses and for the same duration. Cycle monitoring by TVS was started on the 11th of the cycle. At the first follow-up; if the follicle diameter was medium sized [12–15 mm] the starting dose was maintained. Should the growing follicle[s] was smaller; an increment of 37.5 IU was made. The lowest dose that achieved significant follicular increase was maintained until hCG ovulation trigger. Subsequent visits were scheduled according to ovarian response until the leading follicle mean diameter reached ≥18 mm. At this time ovulation was triggered by injection of hCG 10,000 IU [Choriomon, IBSA, Switzerland] and regular sexual relation advised. Cycle cancellation due to non-response was done when no evidence of any follicle >12 mm mean diameter by the 28-35th day of stimulation. Ovulation was documented by TVS 7 days after ovulation triggering and confirmed by assessing midlu