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Patient experience with the copper versus the levonorgesterol-releasing intrauterine device: a randomized controlled trial
246 clinical trials reviewed, 84 (34%) required men to use contraception. While 17 (7%) addressed impairment of sperm, only 9 of these required male contraceptive use. CONCLUSIONS: Literature review identified interventions that pose risks to sperm and offspring of exposed men. Male contraceptive use was not consistently addressed in studies with sperm mutagens. The safe conduct of clinical trials should address the potential risk to male germ cells and future offspring, and require male contraceptive use in studies posing risk. Supported by: Intramural Research Program, Program in Reproductive and Adult Endocrinology and UCSS Clinical Trials Database team of NICHD, NINDS, and CC, NIH.
P-9 Tuesday, October 20, 2009 THE LONG-TERM APOPTOTIC EFFECTS OF PROGESTERONEONLY CONTRACEPTIVES ON ENDOMETRIUM AND OVARY IN ¨ zaksit. Dr. Zekai TaRATS. N. Tasdemir, S. Kilic, N. Lortlar, B. Yuksel, G. O hir BURAK Women Health, Education and Research Hospital, Department of Reproductive Endocrinology and IVF, Ankara, Cankaya, Turkey; Gazi University, Faculty of Medicine, NanoMedicine Research Laboratory, Ankara, Golbasi, Turkey. OBJECTIVE: Apoptosis is necessary for the balance between cell proliferation and cell loss. Various pathologies are related with excessive or deficient apoptosis. We evaluated apoptotic effect of widely used enjectable and implantable progestines on ovarian and uterine tissues via rat study design. DESIGN: Prospective randomise experimental study MATERIALS AND METHODS: Sixtysix Wistar-Albino rats were used. Etonogestrel(IMP) was implanted in 30 rats. Medroksiprogesterone-acetate(MPA) was enjected in another 30 rats. After application of drugs, 6 rats were sacrificed at the each 10th,20th,30th,40th and 50th days. Six rats served as controls. Ovarian and uterine tissues were evaluated for apoptotic index(AI) and caspase-3 immunoreactivity(HSCORE). RESULTS: In both IMP and MPA groups, AI and HScore values in stroma and glandular epithelium of uterus increased with the longer progesterone exposure time. AI and HScore values did not change in endometrium. AI and HScore values also increased with the longer progesterone exposure time in both granulosa and teca-lutein cells of the ovary in IMP and MPA groups. Particularly, increase in AI and HScore values were more prominent after 30 days of progestine exposure for teca-lutein cells of ovary. CONCLUSIONS: Progestine increased apoptosis in ovaries and uterus by the longer exposure time. This effect on uterus is consistent with literature. Apoptotic effect is more prominent by the longer exposure time. Apoptosis increased in ovaries by chronic progesterone exposure which is in contrast with some studies in literature. This effect might be related with chronic supression of gonadotropins and elevation of androgens due to decreased SHBG levels which are indirect effects of progestines. Late reversal of fertility with depot and implant forms of progestines when combined with their apoptotic effects it could be considered that longer duration of progestin usage can cause a shorter period of fertile life. Supported by: NO FINANCIAL SUPPORT
P-10 Tuesday, October 20, 2009 PATIENT EXPERIENCE WITH THE COPPER VERSUS THE LEVONORGESTEROL-RELEASING INTRAUTERINE DEVICE: A RANDOMIZED CONTROLLED TRIAL. K. P. Wright, R. Mojdehi, P. R. Casson, J. V. Johnson. Obstetrics, Gynecology and Reproductive Sciences, University of Vermont College of Medicine, Burlington, VT; Obstetrics and Gynecology, University of Massachusetts Medical School, Worcester, MA. OBJECTIVE: To evaluate bleeding patterns, endometrial thickness and patient satisfaction with a levonorgesterol intrauterine device (L-IUD) vs. a copper IUD (C-IUD). DESIGN: Single blind prospective randomized trial, patient survey, bleeding diaries and ultrasound MATERIALS AND METHODS: This is a preliminary sub-group analysis of patient experience in a trial designed to assess the effect of IUDs on coagulation. Women aged 18-52 were randomized to the L-IUD or the C-IUD. Bleeding diaries were completed for one cycle prior to IUD insertion and again 2-4 months post-IUD insertion. A patient satisfaction survey was conducted 4 months after insertion. Follicular phase endometrial thickness was assessed via transvaginal ultrasound prior to IUD insertion and 4 months post-insertion.
FERTILITY & STERILITYÒ
RESULTS: Eleven patients were randomized to the C-IUD and 7 were randomized to the L-IUD. The most common reasons for choosing the IUD were desire for contraception that was long-term (94%), reversible (83%), effective (72%), didn’t require remembering (72%), and avoided systemic hormones (50%). Patients randomized to the C-IUD had an increase in number of days of spotting (1.45 vs. 3.54, p¼0.02) and heavy bleeding (0.91 vs. 1.82, p¼0.04) compared while patients randomized to the L-IUD had a decrease in days of heavy bleeding (1.86 vs. 0.57, p¼0.01) compared to pre-insertion. Comparing the two groups post-IUD insertion, patients randomized to the L-IUD had significantly fewer days of heavy bleeding compared to patients randomized to the C-IUD (p¼0.0002). Other bleeding parameters (spotting, light, moderate, and heavy bleeding) were unchanged. Endometrial thickness was significantly reduced 4 months post-IUD insertion in the L-IUD group compared to the C-IUD group (4.74 vs. 3.17 mm, p¼0.03). Patient satisfaction averaged 4.4 on a 5 point scale and was not different between groups. CONCLUSIONS: The C-IUD resulted in increased menstrual flow and the L-IUD resulted in decreased flow and endometrial thickness. Patient satisfaction was high for both groups. Supported by: UVM
PREGNANCY LOSS AND TERMINATION P-11 Tuesday, October 20, 2009 PREGNANCY OUTCOME AFTER PGD IN COUPLES WITH RECURRENT MISCARRIAGE AND CARRYING A STRUCTURAL CHROMOSOME ABNORMALITY: A SYSTEMATIC REVIEW. A. Musters, M. Franssen, F. van der Veen, S. Repping, M. Goddijn, J. Korevaar. Academic Medical Center, University of Amsterdam, Amsterdam, NH, Netherlands. OBJECTIVE: Can pre-implantation genetic diagnosis (PGD) increase live birth rates (LBR) in translocation carrier couples with recurrent miscarriages (RM)? DESIGN: Systematic review MATERIALS AND METHODS: MEDLINE and EMBASE databases were searched until April 2009. We searched for randomized control trials and/ or comparative studies comparing PGD with natural conception in couples with RM that carry a structural chromosome abnormality and cohort studies or randomized studies in which PGD or natural conception were compared to another intervention. Patient series and case reports reporting on pregnancy outcome after either natural conception or PGD were also included. RESULTS: We found no randomized controlled trials or non randomized comparative studies with head to head comparison of PGD with natural conception in carrier couples with RM. The search resulted in 22 studies, summarizing the outcome of 128 carrier couples who underwent PGD. LBR (n¼26) in subsequent pregnancies ranged from 0% to 100% (mean 36%; median 28%) per couple. No unbalanced viable offspring was described. Miscarriage rate ranged from 0% to 50% (mean 4%; median 0%) per couple. The wide ranges both in the live birth and miscarriage rates can be explained by the small number of patients included in some studies. Our search identified 3 studies summarizing the outcome of 257 carrier couples who did not undergo PGD but had natural conception. LBR (n¼94) of subsequent pregnancies ranged from 30% to 57% (mean 40%; median 33%) Miscarriage rates of subsequent pregnancies ranged from 22% to 25% (mean 23%; median 23%). Long term live birth rate was 67% for natural conception in carrier couples. The potentially viable unbalanced outcome ranged from 0% to 1% in reported series. CONCLUSIONS: There is insufficient data to recommend PGD as a method to increase LBR in couples with RM that carry a structural chromosome abnormality. Considering their good prognosis towards delivering a healthy child after natural conception, couples should be counseled accordingly.
P-12 Tuesday, October 20, 2009 MISCARRIAGE RATES IN PATIENTS WITH RECURRENT PREGNANCY LOSS (RPL) UNDERGOING OOCYTE DONATION (OD). R. Flyckt, K. O’Leary, L. Shahine, L. Westphal, R. Lathi. Reproductive Endocrinology and Infertility, Stanford University Medical Center, Palo Alto, CA; Obstetrics and Gynecology, University Hospitals/Case Medical Center, Cleveland, OH. OBJECTIVE: Women with RPL are known to have an elevated risk of miscarriage in subsequent pregnancies. Embryonic aneuploidy can explain most
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P-9 Tuesday, October 20, 2009 THE LONG-TERM APOPTOTIC EFFECTS OF PROGESTERONEONLY CONTRACEPTIVES ON ENDOMETRIUM AND OVARY IN ¨ zaksit. Dr. Zekai TaRATS. N. Tasdemir, S. Kilic, N. Lortlar, B. Yuksel, G. O hir BURAK Women Health, Education and Research Hospital, Department of Reproductive Endocrinology and IVF, Ankara, Cankaya, Turkey; Gazi University, Faculty of Medicine, NanoMedicine Research Laboratory, Ankara, Golbasi, Turkey. OBJECTIVE: Apoptosis is necessary for the balance between cell proliferation and cell loss. Various pathologies are related with excessive or deficient apoptosis. We evaluated apoptotic effect of widely used enjectable and implantable progestines on ovarian and uterine tissues via rat study design. DESIGN: Prospective randomise experimental study MATERIALS AND METHODS: Sixtysix Wistar-Albino rats were used. Etonogestrel(IMP) was implanted in 30 rats. Medroksiprogesterone-acetate(MPA) was enjected in another 30 rats. After application of drugs, 6 rats were sacrificed at the each 10th,20th,30th,40th and 50th days. Six rats served as controls. Ovarian and uterine tissues were evaluated for apoptotic index(AI) and caspase-3 immunoreactivity(HSCORE). RESULTS: In both IMP and MPA groups, AI and HScore values in stroma and glandular epithelium of uterus increased with the longer progesterone exposure time. AI and HScore values did not change in endometrium. AI and HScore values also increased with the longer progesterone exposure time in both granulosa and teca-lutein cells of the ovary in IMP and MPA groups. Particularly, increase in AI and HScore values were more prominent after 30 days of progestine exposure for teca-lutein cells of ovary. CONCLUSIONS: Progestine increased apoptosis in ovaries and uterus by the longer exposure time. This effect on uterus is consistent with literature. Apoptotic effect is more prominent by the longer exposure time. Apoptosis increased in ovaries by chronic progesterone exposure which is in contrast with some studies in literature. This effect might be related with chronic supression of gonadotropins and elevation of androgens due to decreased SHBG levels which are indirect effects of progestines. Late reversal of fertility with depot and implant forms of progestines when combined with their apoptotic effects it could be considered that longer duration of progestin usage can cause a shorter period of fertile life. Supported by: NO FINANCIAL SUPPORT
P-10 Tuesday, October 20, 2009 PATIENT EXPERIENCE WITH THE COPPER VERSUS THE LEVONORGESTEROL-RELEASING INTRAUTERINE DEVICE: A RANDOMIZED CONTROLLED TRIAL. K. P. Wright, R. Mojdehi, P. R. Casson, J. V. Johnson. Obstetrics, Gynecology and Reproductive Sciences, University of Vermont College of Medicine, Burlington, VT; Obstetrics and Gynecology, University of Massachusetts Medical School, Worcester, MA. OBJECTIVE: To evaluate bleeding patterns, endometrial thickness and patient satisfaction with a levonorgesterol intrauterine device (L-IUD) vs. a copper IUD (C-IUD). DESIGN: Single blind prospective randomized trial, patient survey, bleeding diaries and ultrasound MATERIALS AND METHODS: This is a preliminary sub-group analysis of patient experience in a trial designed to assess the effect of IUDs on coagulation. Women aged 18-52 were randomized to the L-IUD or the C-IUD. Bleeding diaries were completed for one cycle prior to IUD insertion and again 2-4 months post-IUD insertion. A patient satisfaction survey was conducted 4 months after insertion. Follicular phase endometrial thickness was assessed via transvaginal ultrasound prior to IUD insertion and 4 months post-insertion.
FERTILITY & STERILITYÒ
RESULTS: Eleven patients were randomized to the C-IUD and 7 were randomized to the L-IUD. The most common reasons for choosing the IUD were desire for contraception that was long-term (94%), reversible (83%), effective (72%), didn’t require remembering (72%), and avoided systemic hormones (50%). Patients randomized to the C-IUD had an increase in number of days of spotting (1.45 vs. 3.54, p¼0.02) and heavy bleeding (0.91 vs. 1.82, p¼0.04) compared while patients randomized to the L-IUD had a decrease in days of heavy bleeding (1.86 vs. 0.57, p¼0.01) compared to pre-insertion. Comparing the two groups post-IUD insertion, patients randomized to the L-IUD had significantly fewer days of heavy bleeding compared to patients randomized to the C-IUD (p¼0.0002). Other bleeding parameters (spotting, light, moderate, and heavy bleeding) were unchanged. Endometrial thickness was significantly reduced 4 months post-IUD insertion in the L-IUD group compared to the C-IUD group (4.74 vs. 3.17 mm, p¼0.03). Patient satisfaction averaged 4.4 on a 5 point scale and was not different between groups. CONCLUSIONS: The C-IUD resulted in increased menstrual flow and the L-IUD resulted in decreased flow and endometrial thickness. Patient satisfaction was high for both groups. Supported by: UVM
PREGNANCY LOSS AND TERMINATION P-11 Tuesday, October 20, 2009 PREGNANCY OUTCOME AFTER PGD IN COUPLES WITH RECURRENT MISCARRIAGE AND CARRYING A STRUCTURAL CHROMOSOME ABNORMALITY: A SYSTEMATIC REVIEW. A. Musters, M. Franssen, F. van der Veen, S. Repping, M. Goddijn, J. Korevaar. Academic Medical Center, University of Amsterdam, Amsterdam, NH, Netherlands. OBJECTIVE: Can pre-implantation genetic diagnosis (PGD) increase live birth rates (LBR) in translocation carrier couples with recurrent miscarriages (RM)? DESIGN: Systematic review MATERIALS AND METHODS: MEDLINE and EMBASE databases were searched until April 2009. We searched for randomized control trials and/ or comparative studies comparing PGD with natural conception in couples with RM that carry a structural chromosome abnormality and cohort studies or randomized studies in which PGD or natural conception were compared to another intervention. Patient series and case reports reporting on pregnancy outcome after either natural conception or PGD were also included. RESULTS: We found no randomized controlled trials or non randomized comparative studies with head to head comparison of PGD with natural conception in carrier couples with RM. The search resulted in 22 studies, summarizing the outcome of 128 carrier couples who underwent PGD. LBR (n¼26) in subsequent pregnancies ranged from 0% to 100% (mean 36%; median 28%) per couple. No unbalanced viable offspring was described. Miscarriage rate ranged from 0% to 50% (mean 4%; median 0%) per couple. The wide ranges both in the live birth and miscarriage rates can be explained by the small number of patients included in some studies. Our search identified 3 studies summarizing the outcome of 257 carrier couples who did not undergo PGD but had natural conception. LBR (n¼94) of subsequent pregnancies ranged from 30% to 57% (mean 40%; median 33%) Miscarriage rates of subsequent pregnancies ranged from 22% to 25% (mean 23%; median 23%). Long term live birth rate was 67% for natural conception in carrier couples. The potentially viable unbalanced outcome ranged from 0% to 1% in reported series. CONCLUSIONS: There is insufficient data to recommend PGD as a method to increase LBR in couples with RM that carry a structural chromosome abnormality. Considering their good prognosis towards delivering a healthy child after natural conception, couples should be counseled accordingly.
P-12 Tuesday, October 20, 2009 MISCARRIAGE RATES IN PATIENTS WITH RECURRENT PREGNANCY LOSS (RPL) UNDERGOING OOCYTE DONATION (OD). R. Flyckt, K. O’Leary, L. Shahine, L. Westphal, R. Lathi. Reproductive Endocrinology and Infertility, Stanford University Medical Center, Palo Alto, CA; Obstetrics and Gynecology, University Hospitals/Case Medical Center, Cleveland, OH. OBJECTIVE: Women with RPL are known to have an elevated risk of miscarriage in subsequent pregnancies. Embryonic aneuploidy can explain most
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