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

Completed · Phase 3

Conditions studied: Progesterone Supplementation in Women Undergoing ART

In brief

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

Key facts

Study ID

NCT03565211

Run by

Ferring Pharmaceuticals

People needed

352

Starts

2018-07-26

Expected to finish

2019-07-29

Last updated by the study team

2020-11-23

Who can join

Age: 18 and older, up to 34. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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