Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures

NCT03565211 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 000293
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Progesterone Supplementation in Women Undergoing ART

Keywords

Progesterone vaginal ring (PVR); Vaginal progesterone ring; Assisted reproductive technology (ART); Infertility

Outcome Measures

Primary Outcomes (1)

• Cumulative Rate of Spontaneous Abortions Occurring on or Before 12 Weeks Post-oocyte Retrieval

  Frequency of participants with spontaneous abortions on or before 12 weeks post-oocyte retrieval and undergoing fresh embryo transfer was presented. Spontaneous abortion was defined as two positive beta-human chorionic gonadotropin (β-hCG) tests occurring at least two days apart on or after 2 weeks post-oocyte retrieval, but followed by observation of any empty intrauterine gestational sac (blighted ovum), intrauterine gestation without a fetal heart beat, or absence of viable fetuses, as documented by transvaginal ultrasound (TVUS).

  On or before 12 weeks post-oocyte retrieval

Secondary Outcomes (19)

• Cumulative Rate of Spontaneous Abortions Occurring at 6 Weeks Post-oocyte Retrieval

  At 6 weeks post-oocyte retrieval

• Cumulative Rate of Spontaneous Abortions Occurring at 10 Weeks Post-oocyte Retrieval

  At 10 weeks post-oocyte retrieval

• Cumulative Rate of Biochemical Abortion Within 6 Weeks Post-oocyte Retrieval

  Within 6 weeks post-oocyte retrieval

• Cumulative Rate of Biochemical Abortion Within 10 Weeks Post-oocyte Retrieval

  Within 10 weeks post-oocyte retrieval

• Positive β-hCG Rate at 2 Weeks and 2 Weeks +3-4 Days Post Oocyte Retrieval

  At 2 weeks and 2 weeks +3-4 Days post oocyte retrieval

Study Arms (1)

Progesterone vaginal ring (PVR)

EXPERIMENTAL

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.

Drug: Progesterone vaginal ring

Interventions

Progesterone vaginal ring DRUG

A flexible, non-degradable PVR containing progesterone in micronized formulation and dispersed evenly throughout the ring.

Progesterone vaginal ring (PVR)

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: Pre-menopausal females aged 18-34 years.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (15)

Fertility Treatment Center

Tempe, Arizona, 85284, United States

Location

HRC Fertility

Encino, California, 91436, United States

Location

Reproductive Associates of DE

Newark, Delaware, 19713, United States

Location

Women's Medical Research Group

Clearwater, Florida, 33759, United States

Location

Center for Reproductive Medicine

Winter Park, Florida, 32789, United States

Location

Idaho Center for Reproductive Medicine

Boise, Idaho, 83702, United States

Location

InVia Fertility

Hoffman Estates, Illinois, 60169, United States

Location

Carolina Conceptions

Raleigh, North Carolina, 27607, United States

Location

Abington Reproductive Medicine

Abington, Pennsylvania, 19046, United States

Location

Main Line Fertility Center

Bryn Mawr, Pennsylvania, 19010, United States

Location

Center for Assisted Reproduction

Bedford, Texas, 76022, United States

Location

Houston Fertility Institute

Houston, Texas, 77063, United States

Location

Center of Reproductive Medicine

Webster, Texas, 77598, United States

Location

Utah Fertility Center

Pleasant Grove, Utah, 84062, United States

Location

Eastern Virginia Medical School | EVMS Obstetrics & Gynecology

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Global Clinical Compliance
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

+1 833-548-1402

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label trial
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 21, 2018
• Study Start: July 26, 2018
• Primary Completion: July 29, 2019
• Study Completion: July 29, 2019
• Last Updated: November 23, 2020
• Results First Posted: November 23, 2020

Record last verified: 2020-07

Locations

US (15)