Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures
NCT ID: NCT03565211
Last Updated: 2020-11-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
352 participants
INTERVENTIONAL
2018-07-26
2019-07-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Progesterone vaginal ring (PVR)
Treatment started on the day following oocyte retrieval and could be continued through Week 12 of pregnancy (10 weeks post-oocyte retrieval), depending on the participants pregnancy assessment. A new PVR was inserted every 7 days with up to 10 PVRs used.
Progesterone vaginal ring
A flexible, non-degradable PVR containing progesterone in micronized formulation and dispersed evenly throughout the ring.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Progesterone vaginal ring
A flexible, non-degradable PVR containing progesterone in micronized formulation and dispersed evenly throughout the ring.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Documentation of a normal uterine cavity by hysteroscopy, hydrosonogram, or hysterosalpingogram within one year of screening.
* Normal Pap smear test within 24 months of screening.
* At least one cycle without reproductive hormone medication prior to screening follicle-stimulating hormone (FSH) and estradiol blood draw.
* Tubal, idiopathic, male factor, ovulatory dysfunction, or endometriosis-linked infertility.
Exclusion Criteria
* FSH greater than 15 IU/L during the early follicular phase (Day 2-4). For those participants with polycystic ovarian syndrome, a Day 2-4 FSH level can be obtained following a progestogen withdrawal or spontaneous menses.
* Clinically significant gynecologic pathology, such as submucosal fibroids, intramural fibroids \>5 cm, communicating hydrosalpinx, uncorrected uterine septum, endometrial cancer or endometrial atypia, scar tissue inside the cavity or poorly developed uterine lining from prior uterine surgery, pelvic tuberculosis, or any other conditions that could adversely affect pregnancy success.
* Uncontrolled elevation of prolactin or too little thyroid hormone in the blood.
* History of more than one failed fresh in vitro fertilization cycle. A failed cycle is defined as having started a cycle and not becoming pregnant or pregnancy loss prior to the 20th week of pregnancy.
18 Years
34 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ferring Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fertility Treatment Center
Tempe, Arizona, United States
HRC Fertility
Encino, California, United States
Reproductive Associates of DE
Newark, Delaware, United States
Women's Medical Research Group
Clearwater, Florida, United States
Center for Reproductive Medicine
Winter Park, Florida, United States
Idaho Center for Reproductive Medicine
Boise, Idaho, United States
InVia Fertility
Hoffman Estates, Illinois, United States
Carolina Conceptions
Raleigh, North Carolina, United States
Abington Reproductive Medicine
Abington, Pennsylvania, United States
Main Line Fertility Center
Bryn Mawr, Pennsylvania, United States
Center for Assisted Reproduction
Bedford, Texas, United States
Houston Fertility Institute
Houston, Texas, United States
Center of Reproductive Medicine
Webster, Texas, United States
Utah Fertility Center
Pleasant Grove, Utah, United States
Eastern Virginia Medical School | EVMS Obstetrics & Gynecology
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
000293
Identifier Type: -
Identifier Source: org_study_id