A prospective, randomized, controlled study to compare two doses of

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Sep 26, 2009 - The aim of our study is to compare two doses of recombinant. hCG in women .... Chang P, Kenley S, Burns T, Denton G, Currie K,. DeVane G, et ...
A prospective, randomized, controlled study to compare two doses of recombinant human chorionic gonadotropin in serum and follicular fluid in woman with high body mass index This prospective, randomized, controlled study compares the efficiency of 250 mg or 500 mg of recombinant hCG in serum and follicular fluid (FF) levels and pregnancy rates (PR) in women with high body mass index (BMI) (R26 kg/m2) undergoing assisted reproduction treatment (ART). Treatment outcomes are similar between the two groups. (Fertil Steril 2010;93:2084–7. 2010 by American Society for Reproductive Medicine.)

Final maturation of the oocytes is achieved through the administration of a timed injection of hCG. The success of mature oocyte retrieval is dependent on serum concentrations of hormone reaching values capable of initiating meiosis and triggering the release of the cumulus–oocyte complex into the follicular fluid (FF) (1). For decades hCG derived from urine was available and used during IVF cycles. More recently recombinant hCG became available. Several clinical studies have shown that the two hCG preparations had a similar results in terms of obtained number of oocytes, clinical and ongoing pregnancies, delivery and miscarriage rates (2–7). The effectiveness of 250 and 500 mg of recombinant hCG, which represented the lower and upper limits of the dose range, were compared to induce final oocyte maturation during IVF/intracytoplasmic sperm injection (ICSI) cycles and were found to be equally effective (8). However, the problem of high body mass index (BMI) and response in obese patients to a standard amount of hCG may be an inherent problem of obesity and there are no data available yet on the use of recombinant hCG in obese patients (5). It may not be solved by a recombinant product as with urinary hCG. The adverse effect of obesity on natural fecundity has been reported (9, 10). In women undergoing assisted reproduction techniques (ART), obesity has been associated with the need for higher doses of gonadotropins, increased cycle cancellation rates, and fewer oocytes retrieved (11). Lower rates of embryo transfer, pregnancy, and live birth have also been reported, as have higher miscarriage rates (11, 12). Therefore it is not clear which dose of Semra Kahraman, M.D. Guvenc Karlikaya, M.D. Mustecep Kavrut, M.D. Hale Karagozoglu, M.D. Istanbul Memorial Hospital, IVF and Reproductive Genetics Unit, Istanbul, Turkey Received February 23, 2009; revised July 20, 2009; accepted August 7, 2009; published online September 26, 2009. S.K. has nothing to disclose. G.K. has nothing to disclose. M.K. has nothing to disclose. H.K. has nothing to disclose. Reprint requests: Semra Kahraman, M.D., Istanbul Memorial Hospital, Piyale Pasa Bulvari Okmeydani-Sisli 34385, Istanbul, Turkey (FAX: þ90 212 314 66 49;; E-mail: [email protected]).

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recombinant hCG, 250 mg or 500 mg, is an effective dose to induce final oocyte maturation in obese patients, as there is no data in the literature. The aim of our study is to compare two doses of recombinant hCG in women with high BMI. To our knowledge this is the first study comparing the effectiveness of two recombinant hCG doses in obese woman in terms of serum and FF hCG levels, total and metaphase II (MII) oocytes obtained, and clinical parameters achieved. This prospective, controlled randomized study was done between December 2007 and December 2008 in Istanbul Memorial Hospital. The study was approved by the Institutional Review Board (IRB) of our institution and written consent was obtained from all participants. Patients with a BMI of 26 kg/m2 or higher (range 26–38 kg/m2) were accepted as eligible for the trial. Exclusion criteria included polycystic ovary syndrome (PCOS), a history of bad response to controlled ovarian hyperstimulation (COH), and a high basal FSH level >12 IU/mL. Patients underwent ovarian stimulation by standard midluteal phase GnRH agonist (Lucrin; Abbott, Abbott Park, IL) or GnRH antagonist (Cetrotide; Merck Serono, Istanbul, Turkey). Ovarian stimulation was administrated as recombinant FSH (Gonal-F; Merck Serono). When two or more follicles had attained a minimum mean diameter of 18 mm, follicular maturation was achieved using either 250 mg of recombinant hCG SC (Ovitrelle; Merck Serono, Geneva, Switzerland) or 500 mg of recombinant hCG SC according to a computer-based randomization list. Transvaginal ultrasound (TVUS)-guided oocyte retrieval was performed 36 hours after administration of recombinant hCG injection. After the retrieval, the oocytes were evaluated for maturity and ICSI was used for fertilization. The embryos were cultured 3–5 days before the transfer. The day of transfer and the number of embryos transferred were decided by the physician based on patient and cycle characteristics. Progesteron supplementation was continued until week 10 of pregnancy. Blood samples were taken from the antecubital vein just before the oocyte retrieval for determination of hCG concentration using

Fertility and Sterility Vol. 93, No. 6, April 2010 Copyright ª2010 American Society for Reproductive Medicine, Published by Elsevier Inc.

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an automated system. Follicular fluid aspirates were collected from several follicles. Pooled samples were stored at -20 C. Thawed aspirates of each patient’s pooled FF were centriufigated to remove blood and granulosa cells (GC). To analyze serum and each patient’s pooled FF concentrations of hCG, an automated chemiluminescence immunoassay (cobas; Roche Diagnostics, Indianapolis, IN) was used. The lower detection level of hCG was