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

Ferring

Status and phase: Completed; Phase 3

Conditions: Progesterone Supplementation in Women Undergoing ART

Treatments: Drug: Progesterone vaginal ring

Study type: Interventional

Funder types: Industry

Identifiers

NCT03565211

000293

Details and patient eligibility

About

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

Enrollment: 352 patients

Sex: Female

Ages: 18 to 34 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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352 participants in 1 patient group

Progesterone vaginal ring (PVR)

Experimental group

Description:

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.

Treatment:

Drug: Progesterone vaginal ring