IRB Studies
Chlamydia and Tubal Factor Infertility
Enrollment Start Date: November 2012
PI: Harold Wiesenfeld
Genetic Basis of Male Infertility
Enrollment Start Date: May 2012
PI: Alexander Yatsenko
Oocyte Cryopreservation
Enrollment Start Date: July 2011
PI: Shweta Nayak
Ovarian Tissue Cryopreservation
Enrollment Start Date: January 2011
PI: Peter Shaw
Premature Ovarian Insufficiency
Enrollment Start Date: December 2010
PI: Aleksandar Rajkovic
Short Term Genetic Effects of Chemotherapy on Male Germ Cells
Enrollment Start Date: April 2013
PI: Shruti Malik
Testicular Tissue Cryopreservation
Enrollment Start Date: January 2011
PI: Kyle Orwig
Join a Study
- Testicular Tissue Cryopreservation for Fertility Preservation
- Ovarian Tissue Cryopreservation for Fertility Preservation
- Oocyte Cryopreservation for Fertility Preservation
- Genetic Effects of Chemotherapy on Male Germ Cells
- Genetic Basis for Male Infertility
- Premature Ovarian Insufficiency
- Chlamydia and Tubal Factor Infertility
Testicular Tissue Cryopreservation for Fertility Preservation
Principal Investigator: Kyle Orwig, PhD
Inclusion Criteria for enrollment into the Study
Males older than 1 year old with two testes Have a newly diagnosed or recurrent disease that requires chemotherapy or radiation treatment and puts them at high risk for infertility
Description of the Study
The Fertility Preservation Program in Pittsburgh is conducting an experimental research study for young patients facing chemotherapy or radiation therapies that can threaten fertility. For these young patients who are not yet producing mature sperm, the Fertility Preservation Program is approved to freeze testicular or ovarian tissue that might be used in the future to restore fertility when experimental techniques emerge from the research pipeline.
Compensation
The FPP program will cover the costs of surgery, tissue processing, tissue freezing, and the first year of frozen storage.
For more information, please call: The Fertility Preservation Program’s dedicated phone line at 412-641-7475.
Ovarian Tissue Cryopreservation for Fertility Preservation
Principal Investigator: Peter Shaw, MD
Inclusion Criteria for enrollment into the Study
- Females age 1 to 40 with two ovaries
- Have a newly diagnosed or recurrent disease that requires chemotherapy or radiation treatment and puts them at high risk for infertility
Description of the Study
The Fertility Preservation Program in Pittsburgh is conducting an experimental research study for young patients facing chemotherapy or radiation therapies that can threaten fertility. For these young patients who are not yet producing mature eggs, the Fertility Preservation Program is approved to freeze testicular or ovarian tissue that might be used in the future to restore fertility when experimental techniques emerge from the research pipeline.
Compensation
The FPP program will cover the costs of surgery, tissue processing, tissue freezing, and the first year of frozen storage.
For more information, please call: The Fertility Preservation Program’s dedicated phone line at 412-641-7475.
Oocyte Cryopreservation for Fertility Preservation
Principle Investigator: Shweta Nayak, MD
Inclusion Criteria for enrollment into the Study
- Girls and women ages 14 through 40 who have been diagnosed with a condition which may impair their fertility, or a condition that requires treatment that may impair fertility (such as chemotherapy or radiation)
- Women ages 18 through 40 who plan to delay childbearing until their later reproductive years • Normal ovarian reserve, as measured through blood tests and pelvic ultrasound, is required for participation
- Participants must not have any medical contraindications to ovarian stimulation or vaginal egg retrieval
Description of the Study
The Fertility Preservation Program (FPP) in Pittsburgh is conducting an experimental research study evaluating the ability of mature oocytes (eggs) that have been frozen to be fertilized and achieve pregnancy. Additionally, pregnancy outcomes resulting from previously frozen eggs will be evaluated. Girls and women who face a threat to their fertility, either from medical conditions that can impair fertility or from age-related decline in fertility may be eligible.
Cost
Study participants will not be compensated for participation, and will incur the costs associated with ovarian stimulation, oocyte retrieval and processing. Patients who have recently been diagnosed with cancer may qualify for financial discounts to participate in the study through the Sharing Hope Program.
For more information please call: The Fertility Preservation Program’s dedicated phone line at 412.641.7475.
Genetic Effects of Chemotherapy on Male Germ Cells
Principal Investigator: Shruti Malik, MD
Inclusion Criteria for enrollment into the study
- Adult males ages 18 through 50
- Scheduled to undergo treatment with chemotherapy for a medical indication
- Participants must not have any prior chemotherapy or radiation treatments
- Participants with oligospermia (very low sperm counts) or azospermia (absent sperm count) will be excluded
Description of the Study
The Fertility Preservation Program in Pittsburgh is conducting an experimental research study for adult male patients facing chemotherapy treatment. For these patients, semen will be collected prior to chemotherapy and after initiating chemotherapy. The majority of the sample collected before chemotherapy will be reserved for your clinical use in the future.
Compensation
Study participants who complete the study will receive $263. Your insurance provider will be charged for the costs of semen analysis and collection of the sample taken before chemotherapy as this is standard of care. You will be responsible for the cost of semen cryopreservation and storage. You will not be charged any fees associated with semen samples collected after chemotherapy as these are research only samples.
For more information, please call: The Fertility Preservation Program’s dedicated phone line at 412-641-7475.
Genetic Basis for Male Infertility
Principal Investigator: Alexander Yatsenko, PhD
Inclusion Criteria for enrollment into the study
- Adult males ages 21 through 64
- Unsuccessful at conceiving with unprotected intercourse for at least 12 months
- Participants must not have any prior chemotherapy or radiation treatments nor a history of cryptorchidism, drug use, or prior surgery for bladder and prostate procedures
- Participants must not have a history of genetic syndromes associated with infertility (Noonan, Klinefelter syndrome, Fanconi Anemia, Myotonic Dystrophy, Beckwith-Wiedemann, Cystic fibrosis)
- Sperm counts should be less than 5 x106 sperm/ml without obstruction (severe oligo- or azoospermia), or participants may have normal counts with abnormal morphology
Description of the Study
The Fertility Preservation Program in Pittsburgh is conducting a research study for adult male patients facing infertility. Infertility affects approximately 10 to 15 percent of American couples, with male infertility accounting for 50 percent of the cases. Sometimes a cause is identified, but many cases of male infertility have an unknown cause. By studying the unique genetic makeup of men with this condition, we may gain insights into the disease process and, in the future, be able to offer better diagnostics and therapies to men with infertility. Early screening and comprehensive genetic testing for conditions that may affect male fertility or pregnancy outcomes will be provided at no cost to study participants. For these patients, a semen analysis will be done at Magee-Womens Hospital on the 5th floor in the Reproductive Endocrinology and Infertility Clinic (REI), and a blood draw of approximately 12cc of blood. Both of which can be done on the same day.
Compensation
Study participants will not receive any compensation for participation in the study. The study is completely voluntary and confidential. It also is of no cost to the participant
Premature Ovarian Insufficiency
Principal Investigator: Aleksandar Rajkovic, MD, PhD
Inclusion Criteria for enrollment into the Study
- Females ages 14 through 64
- Cessation of menstruation prior to age 40
- FSH levels measured on two separate blood draws greater than 40IU/liter
Women must be diagnosed with POF in order to be enrolled in the study regardless of known causation
- Women with surgical menopause will be excluded
Description of the study
Many cases of premature ovarian insufficiency and infertility have an unknown cause. By studying the unique genetic makeup of women with this disease as well as women without, we may gain insights into the disease process and in the future be able to offer better diagnostics and therapies to women with ovarian failure and infertility.
Compensation
Many cases of premature ovarian insufficiency and infertility have an unknown cause. By studying the unique genetic makeup of women with this disease as well as women without, we may gain insights into the disease process and in the future be able to offer better diagnostics and therapies to women with ovarian failure and infertility.
For more information, please call: The Premature Ovarian Insufficiency Study Team at 412-641-5367 or by email at pofstudy@mwri.magee.edu
Chlamydia and Tubal Factor Infertility
Principal Investigator: Harold Wiesenfeld, MD
Inclusion Criteria for enrollment into the Study
- Females ages 18 through 42
- Unsuccessful at conceiving with unprotected intercourse for 12 months
- Eligible if HSG was within the last 12 months
Compensation
Study participants who complete the study will receive $25.
For more information, please call: The study team at 412-400-5556 or by email at hbirkland@yahoo.com
Teresa Erb
Thesis Title: Paracrine & Epigenetic Control of Trophectoderm Differentiation from Human Embryonic Stem Cells: The Role of Bone Morphogenic Protein 4 (BMP4) and Histone Deacetylases (HDACs)
Defense Date: 9/24/2010
Current Position: Reproductive Endocrinologist, Reproductive Health Specialists, Pittsburgh, PA
Serena Dovey
Thesis Title: Feasibility and safety of spermatogonial stem cell transplantation for cancer survivors
Defense Date: 1/30/2012
Current Position: Assistant Professor, Ob/Gyn,
Division of Reproductive Endocrinology & Infertility, Aurora, CO
Melanie Ochalski
Thesis Title: Thalidomide Modulates Ovarian Vascular Dynamics and Attentuates Chemotherapy Damage to Ovarian Folllicles
Defense Date: 1/30/2012
Current Position: Reproductive Endocrinologist, The Fertility Center, York, PA
Shweta Nayak
Thesis Title: Epigenetic Regulation of HistoneGene Expression – Role in Hormone Therapy Resistant Breast Cancer?
Defense Date: 3/4/2013
Current Position: Assistant Professor, Center for Fertility and Reproductive Endocrinology, Pittsburgh, PA
Shruti Malik
Thesis Title: Short-Term Effects of Chemotherapy on Sperm Genetic Integrity & Function of Mice & Men
Current Position: Reproductive Endocrinology & Infertility Fellow
Matrika Johnson
Current Position: Reproductive Endocrinology & Infertility Fellow
Skaznik-Wikiel ME, McGuire MM, Sukhwani M, Donohue J, Chu T, Krivak TC, Rajkovic A, Orwig KE. Granulocyte colony-stimulating factor with or without stem cell factor extends time to premature ovarian insufficiency in female mice treated with alkylating chemotherapy. Fertil Steril 2013; 99:2045-2054.
Dovey SL, Valli H, Hermann BP, Sukhwani M, Donohue J, Castro CA, Chu T, Sanfilippo JS, Orwig KE. Eliminating malignant contamination from therapeutic human spermatogonial stem cells. Journal of Clinical Investigation 2013; 123:1833-1843.
Gassei K and Orwig KE. SALL4 expression in gonocytes and spermatogonial clones of postnatal mouse testes. PLoS ONE 2013; 8:e53976.
Terasawa E, Guerriero KA, Plant TM. Kisspeptin and puberty in mammals. Adv Exp Med Biol. 2013;784:253-73.
Ramaswamy S, Dwarki K, Ali B, Gibbs RB, Plant TM. The Decline in Pulsatile GnRH Release, as Reflected by Circulating LH Concentrations, During the Infant-Juvenile Transition in the Agonadal Male Rhesus Monkey (Macaca mulatta) Is Associated With a Reduction in Kisspeptin Content of KNDy Neurons of the Arcuate Nucleus in the Hypothalamus. Endocrinology. 2013 May;154(5):1845-53.
Alçin E, Sahu A, Ramaswamy S, Hutz ED, Keen KL, Terasawa E, Bethea CL, Plant TM. Ovarian Regulation of Kisspeptin Neurones in the Arcuate Nucleus of the Rhesus Monkey (Macaca mulatta). J Neuroendocrinol. 2013 May;25(5):488-96.
Roth LW, Huang H, Legro RS, Diamond MP, Coutifaris C, Carson SA, Steinkampf MP, Carr BR, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Myers ER, Zhang H, Schlaff WD; Reproductive Medincine Network. Altering hirsutism through ovulation induction in women with polycystic ovary syndrome. Obstet Gynecol 2012; 119: 1151-6.
Diamond MP, Kruger M, Santoro N, Zhang N, Casson P, Schlaff W, Coutifaris C, Brzyski R, Christman G, Carr BR, McGovern PG, Cataldo NA, Steinkampf MP, Gosman GG, Nestler JE, Carson S, Myers EE, Eisenberg E, Legro RS; Eunice Kennedy Shriver National Institutes of Child Health and Human Development Cooperative Reproductive Medicine Network. Endometrial shedding effect on conception and live birth in women with polycystic ovary syndrome. Obstet Gynecol 2012; 119:902-8.
Hermann BP, Sukhwani M, Winkler F, Pascarella JN, Peters KA, Sheng Y, Valli H, Rodriguez M, Esselarab M, Dargo G, Peterson K, Masterson K, Ramsey C, Ward T, Lienesch M, Volk A, Cooper DK, Thomson AW, Kiss JE, Penedo MT, Schatten GP, Shoukhrat M and Orwig KE. Spermatogonial stem cell transplantation into Rhesus testes regenerates spermatogenesis producing functional sperm. Cell Stem Cell 2012 (Featured article); 11:715-26.
Dovey S, Krishnamurti L, Sanfilippo J, Gunawardena S, McLendon P, Campbell M, Alway S, Efymow B, Gracia C. Oocyte cryopreservation in a patient with sickle cell disease prior to hematopoietic stem cell transplantation: first report. J Assist Reprod Genet 2012; 29: 265-9.
Easley CA, Phillips BT, McGuire MM, Barringer JM, Valli H, Hermann BP, Simerly CR, Rajkovic A, Miki T, Orwig KE, Schatten GP. Direct differentiation of human pluripotent stem cells into haploid spermatogenic cells. Cell Reports 2012; 3:440-6.
Suzuki H, Ahn HW, Chu T, Bowden W, Gassei K, Orwig K, Rajkovic A. SOHLH1 and SOHLH2 coordinate spermatogonial differentiation. Dev Biol. 2012; 361:301-12.
Majumdar SS, Sarda K, Bhattacharya I, Plant TM. Insufficient androgen and FSH signaling may be responsible for the azoospermia of the infantile primate testes despite exposure to an adult-like hormonal milieu. Hum Reprod. 2012 Aug;27(8):2515-25.
Plant TM. A comparison of the neuroendocrine mechanisms underlying the initiation of the preovulatory LH surge in the human, Old World monkey and rodent. Front Neuroendocrinol. 2012 Apr;33(2):160-8.
Simorangkir DR, Ramaswamy S, Marshall GR, Roslund R, Plant TM. Sertoli cell differentiation in rhesus monkey (Macaca mulatta) is an early event in puberty and precedes attainment of the adult complement of undifferentiated spermatogonia. Reproduction. 2012 Apr;143(4):513-22.
Mattison DR, Plant TM, Lin HM, Chen HC, Chen JJ, Twaddle NC, Doerge D, Slikker W Jr, Patton RE, Hotchkiss CE, Callicott RJ, Schrader SM, Turner TW, Kesner JS, Vitiello B, Petibone DM, Morris SM. Pubertal delay in male nonhuman primates (Macaca mulatta) treated with methylphenidate. Proc Natl Acad Sci U S A. 2011 Sep 27;108(39):16301-6.
Conley AJ, Plant TM, Abbott DH, Moeller BC, Stanley SD. Adrenal androgen concentrations increase during infancy in male rhesus macaques (Macaca mulatta). Am J Physiol Endocrinol Metab. 2011 Dec;301(6):E1229-35.
Ramaswamy S, Seminara SB, Plant TM. Evidence from the agonadal juvenile male rhesus monkey (Macaca mulatta) for the view that the action of neurokinin B to trigger gonadotropin-releasing hormone release is upstream from the kisspeptin receptor. Neuroendocrinology. 2011;94(3):237-45.
Simpkins JW, Swenberg JA, Weiss N, Brusick D, Eldridge JC, Stevens JT, Handa RJ, Hovey RC, Plant TM, Pastoor TP, Breckenridge CB. Atrazine and breast cancer: a framework assessment of the toxicological and epidemiological evidence. Toxicol Sci. 2011 Oct;123(2):441-59.
Conley AJ, Moeller BC, Nguyen AD, Stanley SD, Plant TM, Abbott DH. Defining adrenarche in the rhesus macaque (Macaca mulatta), a non-human primate model for adrenal androgen secretion. Mol Cell Endocrinol. 2011 Apr 10;336(1-2):110-6.
Clark AT, Phillips BT and Orwig KE. Fruitful progress to fertility: Male fertility in the test tube. Nat Med. 2011; 17:1564-5.
Hermann BP, Sukhwani M, Salati J, Sheng Y, Chu T, Orwig KE. Separating spermatogonia from cancer cells in contaminated prepubertal primate testis cell suspensions. Human Reproduction. 2011; 26:3222-31.
Ochalski ME, Shuttleworth JJ, Chu T, Orwig KE. Thalidomide treatment attenuates chemotherapy-induced gonadal toxicity. Fertil Steril 2011; 95:819.
Nayak SR, Wakim AN. Random-start gonadotropin-releasing hormone (GnRH) antagonist-treated cycles with GnRH agonist trigger for fertility preservation. Fertil Steril 2011; 96: e51-4.
Ochalski ME, Engle N, Wakim A, Ravnan BJ, Hoffner L, Rajkovic A, Surti U. Complex X chromosome rearrangement delineated by array comparative genome hybridization in a woman with premature ovarian sufficiency. Fertil Steril 2011; 95: 2433.
Erb TM, Schneider C, Mucko SE, Sanfilippo JS, Lowry NC, Desai MN, Mangoubi RS, Leuba SH, Sammak PJ. Paracrine & Epigenetic Control of Trophectoderm Differentiation from Human Embryonic Stem Cells: The Role of Bone Morphogenic Protein 4 and Histone Deacetylases Stem. Cells Dev 2011; 20: 1601-14.
Dovey S, McIntyre K, Jacobson D, Catov J, Wakim A. Is premature LH rise in the absence of increased progesterone detrimental to pregnancy outcome in GnRH antagonist IVF/ICSI cycles? Fertil Steril 2011; 96: 585-9.
Dovey S, Sanfilippo J. Emergency contraception: current options, challenges, and future directions. Open Access Journal of Contraception 2011; 2: 107-17.
Kucherov A, Polotsky AJ, Menke M, Isaac B, McAvey B, Buyuk E, et al. Aromatase inhibition causes increased amplitude, but not frequency, of hypothalamic-pituitary output in normal women. Fertil Steril 2011; 95:2063-6.
