the endocrine profile of patients undergoing laparoscopic ovarian transposition (LOT) prior to radiotherapy for cervical cancer.

DESIGN: A prospective study.

MATERIALS AND METHODS: Patients less than 40-years-old with normal ovarian function and a newly diagnosed squamous cell carcinoma of the
cervix, stage 1B- 2B, were recruited to assess the effect of LOT on ovarian
function. Right LOT, Lt.salpingoophorectomy, and Rt. salpingectomy were
performed prior to radiation therapy. Patients Base line and at 3 monthly
serum FSH, estadiol, and testosterone levels and functional life quality
score (FACT-CX) was obtained at baseline and for six months following
radiotherapy.
RESULTS: There were 216 cervical cancer patients in the study duration.
13 patients underwent LOT; four patients consented for the study. The mean
age was 31.5 years. The mean radiation dose to the transposed ovary was
6.99cGy, range of 0.6 to 18.4 cGy. Serum FSH level was normal at baseline
(mean 6.55, range 3-11mIU/ML). Following radiotherapy, there was a transient elevation of FSH at three months (Mean 51.1, range 35.5 to 80.9 mIU/
ML) which returned to normal at 6 months (mean of 11.7, range of 2.8 to 24.7
mIU/ML). The mean FSH level for patients younger than 35 years at the end
of the study was 4.9mIU/ML compared to a mean of 18.8mIU/ML for subjects aged 35 or older. Estrogen and testosterone were normal. There was no
morbidity from surgery or painful cysts on the transposed ovary or metastasis
on resected ovary. FACT_CX score and sexual function did not change following treatment and was generally lower than non-cancer patients.
CONCLUSIONS: LOT is a safe and a feasible procedure prior to radiotherapy for patients with locally advanced cervical cancer. Results from a limited number of patients showed that the procedure is associated with
a transient elevation of FSH with return to baseline.
Supported by: UW-SMPH funds and BIRCWH to SMS.

P-341 Wednesday, October 21, 2009

ANTIMULLERIAN HORMONE, BUT NOT FOLLICLE STIMULATING HORMONE, REFLECTS DECLINE IN OVARIAN RESERVE
ASSOCIATED WITH ORAL CYCLOPHOSPHAMIDE USE IN WEGENERS GRANULOMATOSIS FOR THE WGET RESEARCH
GROUP. S. D. Copland, M. E. B. Clowse, T.-C. Hsieh, S.-C. Chow,
J. H. Stone. Obstetrics & Gynecology: Reproductive Endocrinology & Fertility, Duke University Medical Center, Durham, NC; Medicine: Rheumatology & Immunology, Duke University Medical Center, Durham, NC; Duke
Clinical Research Institute, Durham, NC; Rheumatology Unit, Massachussets General Hospital, Boston, MA.
OBJECTIVE: Our aim was to determine the effect of cyclophosphamide
(CYC) on ovarian reserve markers antimullerian hormone (AMH) and follicle stimulating hormone (FSH) in patients with Wegeners Granulomatosis
(WG).
DESIGN: Case control study of stored plasma.
MATERIALS AND METHODS: Patients in Wegeners Granulomatosis
Etanercept Trial (WGET) received cyclophosphamide (CYC) for severe
WG and methotrexate for limited WG. The first and last available plasma
samples from the 42 women who were under age 50 at WGET enrollment
were analyzed in duplicate for FSH (ELISA Calbiotech) and AMH (ELISA
DSLabs). Linear regression analysis and Wilcoxon rank sum tests were performed.
RESULTS: While the change in AMH during the study was closely correlated with the dose of CYC received (0.8 ng/mL decline per 10 gms CYC,
p0.009), change in FSH did not correlate with CYC dose. Furthermore,
AMH, but not FSH, exhibited a significant decline in patients receiving
CYC compared to no CYC.
TABLE 1. Change in AMH & FSH from baseline to end of study.

CYC in WGET

No CYC in WGET

Parameter

N Mean  std.

Mean  std.

p-value

Raw Change of AMH

(last visit - baseline)*
Raw Change of FSH
(last visit - baseline)y

11 -2.15  1.94

0.36  0.89

0.011

-1.73  14.08

0.347

22 7.40  18.44 10

*Baseline AMH<0.5 ng/mL excluded.

y
Oral contraceptive pill & GnRH agonist users excluded.

S184

Abstracts

CONCLUSIONS: In this study, AMH was more closely linked to CYC

ovarian damage than FSH. FSH testing was not obtained in the early follicular phase, so was influenced by endogenous estradiol and progesterone
during the ovarian cycle of ovulating women. In the oncofertility setting,
where patients are not routinely seen in the early follicular phase and may
be taking oral contraceptives, AMH is a superior marker of ovarian function.
Supported by: Charles Hammond Research Fund Award.

P-342 Wednesday, October 21, 2009

CONVEYING FUTURE FERTILITY RISK TO PATIENTS PARTICIPATING IN CLINICAL TRIALS USING TOTAL BODY IRRADIATION OR CYTOTOXIC AGENTS. S. K. Nurudeen, B. I. Karp,
M. R. Vieira, S. Liu, A. Idriss, P. Stratton. Obstetrics and Gynecology, Georgetown University Hospital, Washington, DC; Combined NeuroScience IRB,
NIH, Bethesda, MD; Unit on Computer Support Services, NICHD, NIH, Bethesda, MD; Program of Reproductive and Adult Endocrinology, NICHD,
NIH, Bethesda, MD.
OBJECTIVE: To evaluate the information regarding future fertility risk in
clinical trials for pediatric cancer, gynecologic cancer, and stem cell transplant.
DESIGN: Cross-sectional epidemiologic study.
MATERIALS AND METHODS: We reviewed active, on-site NIH Intramural clinical trials for pediatric or gynecologic cancer, or for stem cell transplant. Protocols and their corresponding consent and assent forms were
reviewed for whether future fertility risk was addressed, whether it was anticipated that fertility would be compromised, and if fertility preservation options were offered.
RESULTS: 40 studies met criteria including 22 pediatric cancer, 8 gynecologic cancer, and 10 stem cell transplant studies. Only 10 (25%) protocols
addressed future fertility risk with 8 conveying diminished future fertility
and 2 stating an unknown risk. By contrast, more consents, 16 (47%), addressed fertility risk with 11 conveying diminished future fertility. No
assents discussed future fertility risk. Only two studies presented the
opportunity of fertility preservation by discussing the option of sperm or
egg banking.
CONCLUSIONS: Future fertility risk was addressed more frequently in
consents than in protocols and was never addressed in assents. Although diminished future fertility was acknowledged in two thirds of study documents
addressing fertility risk, the option of fertility preservation was rarely presented. While patients entering clinical trials for cancers and stem cell transplant may be counseled about the immediate reproductive risks, we show that
future fertility is often not considered. With improved long term survival
from these diseases and advances in fertility preservation options, clinical trials with interventions that can impair future fertility should explicitly address
future childbearing potential and preservation.
Supported by: Intramural Research Program, Program in Reproductive
and Adult Endocrinology and UCSS Clinical Trials Database team of
NICHD, NINDS, and CC, NIH. Special thanks to the PRAE and CTDB
teams.

P-343 Wednesday, October 21, 2009

LAPAROSCOPIC ASSISTED INJECTION TRANSPLANTATION OF
VITRIFIED OVARIAN TISSUE IN SHEEP MODEL. A. Kader,
N. Desai, T. Falcone. Womens Health Institute/Center for Surgical Innovation Technology and Education, Cleveland Clinic, Cleveland, OH; Center for
Reproductive Medicine, Cleveland Clinic, Cleveland, OH; Department of
Obstetrics and gynecology, Alexandria University, Alexandria, Egypt.
OBJECTIVE: We hypothesized that transplanting fragmented ovarian tissue might improve revascularization and vitrification may be a better approach for the ovarian fragments preservation. The objective of this pilot
was to evaluate the techniques of laparoscopic assisted injection transplantation of vitrified warmed ovarian tissue fragments in sheep model.
DESIGN: Prospective in vivo animal study.
MATERIALS AND METHODS: Five Merino sheep were used in the
study. After laparoscopic bilateral oophorectomy, the ovarian cortices were
fragmented into 0.125mm3 cubes using a tissue chopper. Cortical fragments
were then vitrified in the Ohio-Cryo. After 2 weeks, the ovarian tissue fragments were warmed then suspended in MEM containing 20% platelet rich
sheep serum. Laparoscopic assisted transplantation was carried out by

Vol. 92., No. 3, Supplement, September 2009