Clinical Studies

UCSD Fourth Trimester Center Project

Sponsor: Conrad Prebys

Inclusion: 18+ years old, English or Spanish speaking, delivered a baby in San Diego within the past 12 weeks

Exclusion: Under 18 years old, delivered a baby more than 12 weeks prior and/or outside of San Diego County

Sarah Averbach, MD, MAS

Collaborators: co-I Ukachi Emeruwa, MD, MPH

Postpartum Integration of Vaccines and Contraception Trial (PIVoT)

Sponsor: NIH

NCT05732142-ClinicalTrials.gov

Inclusion: Postpartum people aged 18 and older, reside in rural Maharashtra, speak Marathi, delivered a baby within the past 8 weeks but did not undergo sterilization, hysterectomy or immediate postpartum IUD placement and do not have a new pregnancy.

Exclusion: Under 18 years old, delivered a baby more than 8 weeks prior or planning to move out of the study area within the next 6 months.

Sarah Averbach, MD, MAS

Collaborators: National Institue of Reproductive and Child Health, India; Center for Gender Equity and Health UCSD

Acrivon ACR-368-201/GOG-3082: A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination with Gemcitabine in Adult Subjects with Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature Status

Sponsor: Acrivon Therapeutics, Inc.

Nuvectis GOG-3087 / ENGOT-GYN5 / NCRI / NXP800-101: A Phase 1 Clinical Study of NXP800 in Subjects with Advanced Cancers and Expansion in Subjects with Ovarian Cancer

Sponsor: Nuvectis Pharma, Inc.

GOG Foundation No. GOG-3043: A Randomized Controlled Trial of Robotic versus Open Radical Hysterectomy for Cervical Cancer (ROCC trial)

Sponsor: GOG Foundation, Inc.

K-Group Beta ZN-c3-005 / GOG-3066: A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN‑c3 in Subjects with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Sponsor: K-Group Beta, Inc.

ImmunoGen: GOG-3078 IMGN853-0421: Randomized, multicenter, open-label, phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRα-positive recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after second line platinumbased chemotherapy plus bevacizumab (GLORIOSA)

Sponsor: IMMUNOGEN, INC.

Leah Lamale-Smith, MD

Collaborators: Dora Melber

Leah Lamale-Smith, MD

Collaborators: MFM Faculty and Fellows

Multi-Omics for Maternal Health after Preeclampsia (MOM-Health)

Sponsor: NIH

Inclusion:

• Pregnant women 18 years of age to 50 years of age
• 10-24 weeks gestation at time of enrollment
• Singleton pregnancy
• Planning to deliver at JMC L&D or HC L&D

Exclusion:

• Inability to give informed consent
• Intrauterine fetal demise
• Fetal genetic or structural anomaly
• Institutionalization for psychiatric disorder, mental deficiency or incarcerated
• Active or history of malignancy requiring major surgery or systemic chemotherapy
• Multi-fetal gestation or a twin demise at any gestational age
• Known maternal or fetal chromosomal anomalies
• Patients who plan to keep their placenta after delivery

Louise Laurent, MD, PhD

Collaborators: UCSD: Marni Jacobs (MPI); Mariko Horii; Mana Parast; Katie Fisch. VUMC: Kate Lindley; Ravi Shah; Piper Below

Validation of a cost-effective high-throughput respiratory pathogen diagnostic panel

Sponsor: UCSD Departmental (Pediatrics)

Inclusion:

• Age >= 3 months of age
• Has symptoms of a respiratory infection and is getting a clinical respiratory pathogen test at UCSD and RCHSD

Exclusion:

• Institutionalization for psychiatric disorder, developmental delay, or criminal activity
• Inability to provide informed consent (or have a parent provide informed consent) in either English or Spanish

Louise Laurent, MD, PhD

UCSD Omics Data Generation Center (ODGC) for the Acute to Chronic Pain Signatures (A2CPS) Program

Sponsor: NIH

No enrollment at UCSD

Louise Laurent, MD, PhD

CO-CREATE-Ex: Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences

Discover cocreate.ucsd.edu

Sponsor: NIH

Inclusion:

Cohort 1 Community and Scientific Advisory Board:

• Age 18 years or older
• Speak Spanish or English

Cohort 2 Testing Group:

• Speak Spanish and/or English.
• Affiliated with San Ysidro Health as a patient at select clinics (San Ysidro, Chula Vista, Lincoln Park, and Logan Heights) OR
• A member of a community near a SYH clinic (San Ysidro, Chula Vista, Lincoln Park, and Logan Heights).
• Ages 2 and older (for use of FDA-authorized antigen test kits)

Cohort 3 Healthcare Providers/Staff/Administrators:

• Speaks Spanish and/or English.
• Employed as a SYH clinical provider, administrator, or clinical staff member at a participating clinic

Exclusion: An individual who meets any of the following criteria will be excluded from participation in this study:  

• Institutionalization for psychiatric disorder, developmental delay, or criminal activity
• Unable to provide informed consent.
• Participant is under the age of 2 years old for antigen test kit use.

Louise Laurent, MD, PhD

Uncovering the etiologies of non-immune hydrops fetalis through comprehensive genomic analyses and phenotyping

Sponsor: UCSF(NIH)

Inclusion: Non-diagnostic results of chromosomal microarray and/or karyotype AND No evidence of:

• i) Clinically significant abruption that is suspected to underlie NIHF
• ii) Twin-twin transfusion syndrome in monochorionic twins;
• iii) Clear fetal viral infection;
• iv) Alloimmunization.

AND ONE OF THE FOLLOWING

• i) Increased nuchal translucency or cystic hygroma ≥5 mm WITHOUT any additional fetal effusions or anomalies;

AND/OR

• ii) Increased nuchal translucency or cystic hygroma ≥3.5 mm AS WELL AS either any additional fetal effusions or congenital anomalies;

AND/OR

• iii) Fetal ascites, pleural effusion, pericardial effusion, AND/OR skin edema identified at any point during gestation, prior to the conclusion of the pregnancy.

Exclusion:

• Not meeting the inclusion criteria.

Louise Laurent, MD, PhD

Collaborators: UCSD MFM team, UCSF MFM team

Non-Invasive Continuous Fetal Monitoring in Obstetric Patients

Sponsor: Wellcome Leap – In Utero

Inclusion:

• Female age ≥18 years of age
• Able to provide informed consent
• Fetal gestational age 24-42 weeks at time of consent
• Surrogates and/or use of donor eggs/donor sperm for conception is allowed

Exclusion:

• Women in active labor
• Infant congenital anomalies
• Prisoners/Institutionalized individuals
• Any other unstable, active medical condition.

Louise Laurent, MD, PhD

Retrospective and prospective data collection of maternal, fetal, and neonatal variables from patients referred to the UC Fetal Consortium with a high-risk pregnancy, pregnancy complication or carrying a fetus with a congenital anomaly

Louise Laurent, MD, PhD

Obtaining Umbilical Cords for Clinical and Non-Clinical Research

Sponsor: Angiocrine Bioscience

Inclusion:

• Female age >18 years of age
• Able to provide informed consent
• Able to provide acceptable answers to Donor/Subject Questionnaire
• Giving birth at a licensed hospital-based Labor and Delivery (L&D) Unit
• Neonatal gestational age 24-42 weeks at time of consent
• History of prolonged rupture of membranes with no maternal fever before birth is allowed
• History of maternal diabetes or hypertension is allowed
• Surrogates and/or use of donor eggs/donor sperm for conception is allowed
• Multiple gestation pregnancy is allowed

Exclusion:

• Women in active labor, as defined by collection site, without an epidural placed
• Placenta previa
• Intra-uterine growth restriction (IUGR)
• History of prolonged rupture of membranes with maternal fever before birth
• Infant congenital anomalies
• 2-vessel umbilical cords
• Prisoners
• History of malignancy in baby’s mother
• History of autoimmune disorders in baby’s mother
• History of exposure/risk factors for transmissible infectious agents including Zika virus
• Unexplained fever, malaise, anorexia, weight loss or night sweats consistent with active infection or inflammation
• Travel to an area where malaria is endemic as defined by the CDC
• At risk for the possible transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD).
• Positive or reactive results for infectious disease tests for the following diseases and organisms: Chagas (T. cruzi), Cytomegalovirus (CMV), Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV), Human T-Lymphotrophic

Louise Laurent, MD, PhD

Longitudinal Biospecimen collection from SARS-CoV-2 infected subjects and controls

Sponsor: Louise Laurent, MD, PhD

Inclusion:

• Age >= 18 years of age.
• Cases: Positive SARS-CoV-2 test. Controls: Negative SARS-CoV-2 (if the subject has signs/symptoms consistent with COVID19, a negative SARS-CoV-2 test has been obtained after onset of symptoms). Vaccination: Persons who are presenting for a COVID vaccine and/or have previously received a COVID vaccine.

Exclusion:

• Institutionalization for psychiatric disorder, mental retardation, or criminal activity.
• Inability to provide informed consent in either English or Spanish.
  

Louise Laurent, MD, PhD

Prenatal and placental evaluation of high risk obstetric patients

Sponsor: NIH

Inclusion criteria for the pregnant group:

• Pregnant patients ≥ 18 years of age.
• Agrees to allow for the placenta to be sent to Pathology for evaluation.

Inclusion criteria for the Non-pregnant group:

• Non-pregnant women ≥ 18 years of age.
• Healthy women with no previous history of chronic hypertension or renal disease.

Exclusion:

• Age < 18.
• Institutionalization for psychiatric disorder; developmental delay; or criminal activity.

Louise Laurent, MD, PhD

Biomarkers predicting onset of spontaneous term labor

Sponsor: UCSD Departmental (OGRS)

Inclusion: GA 38.0 to 38.3; singleton pregnancy; healthy women with no previous poor pregnancy outcome

Exclusion: Planned induction or C/S; maternal or fetal chromosomal abnormalities or major fetal anomaly; prior history of IUGR, NICU admission, preterm birth, IUFD; maternal cTHN, renal disease, lupus, CHD, infarction/stroke, DM 1 or 2, GDM on medication; Hgb <9g/dL

Louise Laurent, MD, PhD

Discovery of maternal circulating biomarkers to distinguish between normal placentation, placenta previa and placenta accreta

Sponsor: UCSD Departmental (OGRS)

Inclusion:

• Pregnant women ≥18 years of age
• Presenting for care in one of the listed health care systems
• Diagnosis of suspected placenta accreta, diagnosed by ultrasound or magnetic resonance imaging
• Planning to deliver within the listed health care system
• Agrees to allow for the placenta to be sent to Pathology for evaluation

Exclusion:

• Age-matched, gestational age matched, prior cesarean status matched, and BMI matched controls
  
• Presenting for care in the listed health care system
• Diagnosis of placenta previa without accreta OR diagnosis of normal placenta, diagnosed by ultrasound or magnetic resonance imaging
  
• Planning to deliver within the listed health care system
• Agrees to allow for the placenta to be sent to Pathology for evaluation
  

Louise Laurent, MD, PhD

Collaborators: Louise Laurent, Mana Parast, Gladys Ramos, UCSD MFM fellows

Continuous glucose monitoring in non-diabetic laboring women

Sponsor: Dexcom

 
Sandy Ramos, MD

Androgen effects on the reproductive neuroendocrine axis

Sponsor: NIH

Antoni Duleba, MD

Collaborators: Tracy Harrison, MD

Association of fertility preservation health insurance benefit mandates with utilization of ART banking and philanthropic fertility drug programs among females newly diagnosed with cancer

Sponsor: Ferring Pharmaceutical

The SAFE Study: Psychosocial Stress And Fertility Outcomes

Sponsor: Academic Senate

Inclusion: Ages 18-42, regular menstrual cycles, undergoing in vitro fertilization

Exclusion: Decreased ovarian reserve

H. Irene Su, MD, MSCE

Collaborators: Sasha Kauffman, PhD, Kellie Breen-Church, PhD, Jamie Stanhiser, MD

Navigating New UC IVF Benefits

Sponsor: UC San Diego

NCT05663645-ClinicalTrials.gov

Inclusion: University of California, San Diego staff or faculty, ages 18-50, intention to attempt pregnancy over the next year

H. Irene Su, MD, MSCE

Collaborators: Mayowa Dayo, MD MPH; Sally Romero, PhD

Telehealth oncofertility care: a stepped wedge cluster randomized controlled trial in pediatric, adolescent and young adult cancer survivors

Sponsor: NCI

NCT05443737-ClinicalTrials.gov

Inclusion: Ages 0-50, newly diagnosed cancer patient, oncology care at UC San Diego, Rady Children's or City of Hope

H. Irene Su, MD, MSCE

Collaborators: Sally Romero, PhD

Intervening on Women’s Health for Rural Young Breast Cancer Survivors

Sponsor: CBCRP

NCT05414812-ClinicalTrials.gov

Inclusion: Ages 0-50, breast cancer survivor, female

H. Irene Su, MD, MSCE

Collaborators: Sally Romero, PhD

H. Irene Su, MD, MSCE

Collaborators: Alison Ting, PhD, Kina Thackray, PhD

Implementation of fertility care for adolescents and young adults with cancer

Sponsor: NCI

H. Irene Su, MD, MSCE

Collaborators: Sally Romero, PhD

Predictors of Ovarian Insufficiency through Serial Exams (POISE) Study in Young Breast Cancer Survivors

Sponsor: ACS, NICHD

H. Irene Su, MD, MSCE

H. Irene Su, MD, MSCE

Collaborators: Gabriel Garzo, MD

Intervening on Reproductive Health in Young Breast Cancer Survivors (SCP-R)

Sponsor: CBCRP

H. Irene Su, MD, MSCE

Collaborators: Sally Romero, PhD

The Reproductive Window in Young Adult Cancer Survivors

Sponsor: NICHD

H. Irene Su, MD, MSCE

Collaborators: Sally Romero, PhD

H. Irene Su, MD, MSCE

H. Irene Su, MD, MSCE

Studying the impact of state-mandated health insurance benefits for fertility preservation services on affordability and access for Hispanic/Latino cancer patients

Sponsor: Robert Wood Johnson Foundation

H. Irene Su, MD, MSCE

Collaborators: Kelly Chacon, MD; Sally Romero, PhD

Policy implementation research on health benefit mandates for fertility preservation services to improve access to care in young cancer survivors.

Sponsor: NCI

H. Irene Su, MD, MSCE

Collaborators: Sally Romero, PhD

Expression and Regulation of RHOX Genes and an X-linked MicroRNACluster

Sponsor: NIH

Miles Wilkinson, PhD

Collaborators: Mike Hsieh (Urology Department, UCSD)

Miles Wilkinson, PhD

Collaborators: Mike Hsieh (Urology Department, UCSD)

Beta-Agonist versus Botox A® Trial for Urgency Urinary Incontinence (BEST)

Sponsor: Patient-Centered Outcomes Research Institute (PCORI)

The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI).

NCT05806164-ClinicalTrials.gov

Discover "BEST" Research Study

Inclusion:

• 18 years or older
• report at least "quite a bit bothered" or worse by their UUI defined by response to OAB-q-SS item #8 "How bothered are you by urine loss associated with a strong desire to urinate?"
• are not and do not plan to become pregnant
• have persistent UUI defined as previous unsuccessful results after conservative and anticholinergic treatment, or are unable to tolerate or have contraindications to anticholinergics
• are currently not taking anticholinergics or are willing to stop medication for 3 weeks prior to enrollment.
• for participants reporting mixed urinary incontinence symptoms, participant must (a) have less bother from SUI than from UUI, defined as a response of "Not at all bothered" or only "a little bit bothered" by SUI on the Urogenital Distress Inventory item "Do you experience urine leakage related to physical activity? (walking, running, laughing, sneezing, coughing), and (b) SUI symptoms be stable (> 3 months), and (c)participant does not desire additional treatment for SUI in the upcoming 3 months.
• Participants after unsuccessful neuromodulation trial can be eligible after a 4-week washout period.

Exclusion:

• clinical contraindication to beta-3 agonist or onabotulinumtoxinA
• prior therapeutic trial of either study treatment
• unevaluated hematuria, current or prior bladder malignancy
• surgically altered detrusor muscle
• prior pelvic radiation
• post-void residual >150 mL in past 3 months
• neurogenic bladder
• pelvic floor surgery within the past 3 months
• anticipating pelvic surgery within primary outcome follow up period (3 months)

Emily Lukacz, MD, MAS

Collaborators: UC San Diego, Women and Infants Hospital of Rhode Island, University of Alabama, University of New Mexico, Howard University, PCORI

San Diego, California 

Providence, Rhode Island

Washington, DC

Birmingham, Alabama

Albuquerque, New Mexico

A Randomized Trial of Transurethral Bulking Agent Injection versus Single-Incision Sling for Stress Urinary Incontinence: The BASIS Trial

Sponsor: NICHD, Pelvic Floor Disorders Network

Inclusion:

• Women ≥21 years with bothersome SUI or stress predominant MUI
• a positive cough stress test or urodynamic SUI within the past 18 months
• normal voiding function as demonstrated by PVR < 150 mL
• failed or unable to perform conservative management for SUI including pelvic floor strengthening
• failed or declines pessary option for SUI
• available for up to 3 years
• agrees to randomization

Exclusion: 

• anterior/apical vaginal prolapse beyond the hymen (>0 on POPQ)
• urge predominant mixed UI by PFDI-20 despite stable medication therapy
• advanced UUI/OA B 3rd line therapy treatment within 1 year of enrollment
• planned hysterectomy, urethral or other pelvic surgeries requiring general anesthesia at the time of SUI treatment, during the last 6 motnhs, or planned within the next 12 months.
• malignancy or history of radiation of the pelvis
• pregnant, post-partum, breastfeeding or plans for pregnancy within 1 year
• incomplete emptying (PVR > 150mL)
  8. prior anti-incontinence procedure
• neurogenic bladder
• prior adverse reaction to synthetic mesh or urethral bulking material
• chronic bladder or pelvic pain conditions
• active treatment for SUI with a pessary (3-week washout prior to assesing baseline measures)

Emily Lukacz, MD, MAS

Collaborators: UC San Diego, Women & Infants Hospital of Rhode Island, Kaiser Permanente Southern Region, University of Texas Southwestern, University of Pennsylvania, Duke University, Universty of Chicago, RTI International, NICHD

San Diego, California

Dallas, Texas

Philadelphia, Pennsylvania

Durham, North Carolina

Providence, Rhode Island

Chicago, Illinois

Training for Urinary Leakage Improvement after Pregnancy (TULIP)

Sponsor: NICHD, Pelvic Floor Disorders Network

• Age ≥18 years primiparous patient status post singleton vaginal delivery (>32 weeks)
• At increased risk of stustand pelvic floor disorders as defined by
  • neonate ≥4kg, and/or
  • operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or
  • 3rd or 4th degree perineal laceration
• Symptomatic, bothersome UI as defiend by a score of ≥6 on the ICIQ-SF
  

• inability to complete study assessments and procedures, per clinical judgement, or not available for 6mo postpartum follow-up
• stillbirth or significant maternal or neonatal illness
• Non-English or Spanish speaking
• perineal wound breakdown or cloaca observed on exam
• severe pain with asessments of PFM integrity and/or strength function
• already engaged (since delivery) in in-person physical therapy for strengthening of the pelvic floor
• unwilling or unable to upload and use external smartphone app(s)

Emily Lukacz, MD, MAS

Collaborators: UC San Diego, Women & Infants Hospital of Rhode Island, Kaiser Permanente Southern Region, University of Texas Southwestern, University of Pennsylvania, Duke University, Universty of Chicago, RTI International, NICHD

San Diego, California

Dallas, Texas

Philadelphia, Pennsylvania

Durham, North Carolina

Providence, Rhode Island

Chicago, Illinois

UTILIZATION OF A LOW FIDELITY PELVIC MODEL IN DEVELOPING TASK-SPECIFIC GYNECOLOGIC SURGICAL SKILLS

Sponsor: UCSD, APGO

Jorge Alvarado, MD

Collaborators: Lisa Brenneman, Yovanni Casablanca, Karim ElSahwi, Bunja Rungruang, Stefani Udea, Fidel Valea

Implementation and evaluation of a virtual reality (VR) platform as a practice and assessment tool for maintaining empathetic communication while managing obstetrics emergencies during the third year medical school OBGYN clerkship

Sponsor: UCSD Sanford Institute for Empathy and Compassion

Julia Cormano, MD

Collaborators: Sean Evans, David Klein, MD Preetham Suresh