Clinical trial NCT03565211: Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures
Official title: A Prospective, Multi-Center, Non-Comparative Trial of the Clinical Safety of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology (ART) Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Progesterone Supplementation in Women Undergoing ART
Keywords: Progesterone vaginal ring (PVR)
Vaginal progesterone ring
Assisted reproductive technology (ART)
Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-06-21
Enrollment: 352
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the safety of Progesterone Vaginal Ring (PVR) in women undergoing fresh embryo transfer (ART).


Eligibility criteria: Inclusion Criteria:

* Pre-menopausal women aged 18-34 at the time of consent.
* 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:

* Body mass index greater than 38 kg/m\^2.
* 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.

Primary outcomes:
measure: Cumulative Rate of Spontaneous Abortions Occurring on or Before 12 Weeks Post-oocyte Retrieval
timeFrame: On or before 12 weeks post-oocyte retrieval
Secondary outcomes:
measure: Cumulative Rate of Spontaneous Abortions Occurring at 6 Weeks Post-oocyte Retrieval
timeFrame: At 6 weeks post-oocyte retrieval
measure: Cumulative Rate of Spontaneous Abortions Occurring at 10 Weeks Post-oocyte Retrieval
timeFrame: At 10 weeks post-oocyte retrieval
measure: Cumulative Rate of Biochemical Abortion Within 6 Weeks Post-oocyte Retrieval
timeFrame: Within 6 weeks post-oocyte retrieval
measure: Cumulative Rate of Biochemical Abortion Within 10 Weeks Post-oocyte Retrieval
timeFrame: Within 10 weeks post-oocyte retrieval
measure: Positive β-hCG Rate at 2 Weeks and 2 Weeks +3-4 Days Post Oocyte Retrieval
timeFrame: At 2 weeks and 2 weeks +3-4 Days post oocyte retrieval
measure: Clinical Pregnancy Rate at 6 Weeks
timeFrame: At 6 weeks post-oocyte retrieval
measure: Clinical Pregnancy Rate at 10 Weeks
timeFrame: At 10 weeks post-oocyte retrieval
measure: Rate of Ectopic and Heterotopic Pregnancies Following Oocyte Retrieval
timeFrame: At 4 weeks +3-4 Days after oocyte retrieval
measure: Rate of Abnormal Findings in Clinical Laboratory Tests (Clinical Chemistry, Hematology, and Urinalysis)
timeFrame: From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval)
measure: Rate of Abnormal Findings in Vital Signs
timeFrame: From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval)
measure: Frequency, Intensity/Grade, Seriousness, and Relatedness of Adverse Events (AEs)
timeFrame: From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval)
measure: Frequency and Intensity/Grade of Vaginal Bleeding/Spotting
timeFrame: From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval)
measure: Frequency and Intensity/Grade of Vaginal Hemorrhage
timeFrame: From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval)
measure: Frequency and Intensity/Grade of Vaginal Pain
timeFrame: From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval)
measure: Frequency and Intensity/Grade of Vaginal Infection
timeFrame: From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval)
measure: Frequency and Intensity/Grade of Vaginal Irritation
timeFrame: From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval)
measure: Frequency, Intensity/Grade, Seriousness, and Relatedness of AEs Associated With Vaginal and Cervical Abrasions and Lesions
timeFrame: From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval)
measure: Frequency, Intensity/Grade, Seriousness, and Relatedness of AEs Associated With Vaginal Adhesions
timeFrame: From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval)
measure: Frequency and Reason for PVR Discontinuation
timeFrame: From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Fertility Treatment Center
state: Arizona
city: Encino
country: United States
facility: HRC Fertility
state: California
city: Newark
country: United States
facility: Reproductive Associates of DE
state: Delaware
city: Clearwater
country: United States
facility: Women's Medical Research Group
state: Florida
city: Winter Park
country: United States
facility: Center for Reproductive Medicine
state: Florida
city: Boise
country: United States
facility: Idaho Center for Reproductive Medicine
state: Idaho
city: Hoffman Estates
country: United States
facility: InVia Fertility
state: Illinois
city: Raleigh
country: United States
facility: Carolina Conceptions
state: North Carolina
city: Abington
country: United States
facility: Abington Reproductive Medicine
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Main Line Fertility Center
state: Pennsylvania
city: Bedford
country: United States
facility: Center for Assisted Reproduction
state: Texas
city: Houston
country: United States
facility: Houston Fertility Institute
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicine
state: Texas
city: Pleasant Grove
country: United States
facility: Utah Fertility Center
state: Utah
city: Norfolk
country: United States
facility: Eastern Virginia Medical School | EVMS Obstetrics & Gynecology
state: Virginia
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: