Phase 3
N=254
Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures
Progesterone Supplementation in Women Undergoing ART
Bottom Line
View on ClinicalTrials.gov: NCT03565211 ↗Enrolled (actual)
254
Serious AEs
1.6%
Results posted
Nov 2020
Primary outcome: Primary: Cumulative Rate of Spontaneous Abortions Occurring on or Before 12 Weeks Post-oocyte Retrieval — 7.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Progesterone vaginal ring (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Rate of Spontaneous Abortions Occurring on or Before 12 Weeks Post-oocyte Retrieval |
7.4 | — |
| SECONDARY Cumulative Rate of Spontaneous Abortions Occurring at 6 Weeks Post-oocyte Retrieval |
5.8 | — |
| SECONDARY Cumulative Rate of Spontaneous Abortions Occurring at 10 Weeks Post-oocyte Retrieval |
7.4 | — |
| SECONDARY Cumulative Rate of Biochemical Abortion Within 6 Weeks Post-oocyte Retrieval |
10.3 | — |
| SECONDARY Cumulative Rate of Biochemical Abortion Within 10 Weeks Post-oocyte Retrieval |
10.3 | — |
| SECONDARY Positive β-hCG Rate at 2 Weeks and 2 Weeks +3-4 Days Post Oocyte Retrieval |
60.9 | — |
| SECONDARY Clinical Pregnancy Rate at 6 Weeks |
44.9 | — |
| SECONDARY Clinical Pregnancy Rate at 10 Weeks |
43.2 | — |
| SECONDARY Rate of Ectopic and Heterotopic Pregnancies Following Oocyte Retrieval |
0.4; 0.0 | — |
| SECONDARY Rate of Abnormal Findings in Clinical Laboratory Tests (Clinical Chemistry, Hematology, and Urinalysis) |
1; 1 | — |
| SECONDARY Rate of Abnormal Findings in Vital Signs |
4; 23; 2; 3; 1; 1 | — |
| SECONDARY Frequency, Intensity/Grade, Seriousness, and Relatedness of Adverse Events (AEs) |
124; 100; 46; 9; 4; 25 | — |
| SECONDARY Frequency and Intensity/Grade of Vaginal Bleeding/Spotting |
4; 3; 1; 1 | — |
| SECONDARY Frequency and Intensity/Grade of Vaginal Hemorrhage |
— | — |
| SECONDARY Frequency and Intensity/Grade of Vaginal Pain |
2; 2; 1; 0; 0; 1 | — |
| SECONDARY Frequency and Intensity/Grade of Vaginal Infection |
4; 3; 1; 0 | — |
| SECONDARY Frequency and Intensity/Grade of Vaginal Irritation |
2; 2; 0; 1; 0; 1 | — |
| SECONDARY Frequency, Intensity/Grade, Seriousness, and Relatedness of AEs Associated With Vaginal and Cervical Abrasions and Lesions |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Frequency, Intensity/Grade, Seriousness, and Relatedness of AEs Associated With Vaginal Adhesions |
— | — |
| SECONDARY Frequency and Reason for PVR Discontinuation |
2; 1; 44; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03565211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.