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

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ClinicalTrials.gov Identifier: NCT03565211
Recruitment Status : Active, not recruiting
First Posted : June 21, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Progesterone Supplementation in Women Undergoing ART Drug: Progesterone vaginal ring (PVR) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open-label trial
Primary Purpose: Treatment
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
Actual Study Start Date : July 26, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Progesterone vaginal ring (PVR) Drug: Progesterone vaginal ring (PVR)
A flexible, non-degradable PVR containing progesterone in micronized formulation and dispersed evenly throughout the ring.




Primary Outcome Measures :
  1. Cumulative rate of spontaneous abortions occurring on or before 12 weeks post-oocyte retrieval [ Time Frame: On or before 12 weeks post-oocyte retrieval ]

    Frequency of subjects with spontaneous abortions on or before 12 weeks post-oocyte retrieval and undergoing fresh embryo transfer will be presented.

    Spontaneous abortion is 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).



Secondary Outcome Measures :
  1. Cumulative rate of spontaneous abortions occurring at 6 weeks post-oocyte retrieval [ Time Frame: At 6 weeks post-oocyte retrieval ]
    Frequency of subjects with spontaneous abortions at 6 weeks post-oocyte retrieval will be presented.

  2. Cumulative rate of spontaneous abortions occurring at 10 weeks post-oocyte retrieval [ Time Frame: At 10 weeks post-oocyte retrieval ]
    Frequency of subjects with spontaneous abortions at 10 weeks post-oocyte retrieval will be presented.

  3. Cumulative rate of biochemical abortion within 6 weeks post-oocyte retrieval [ Time Frame: Within 6 weeks post-oocyte retrieval ]

    Frequency of subjects with biochemical abortions within 6 weeks post-oocyte retrieval will be presented.

    Biochemical abortion is defined as a positive β-hCG test at 2 weeks and 2 weeks + 3-4 Days post-oocyte retrieval, but followed by no observed gestational sac on a later TVUS, or followed by a negative β-hCG test.


  4. Cumulative rate of biochemical abortion within 10 weeks post-oocyte retrieval [ Time Frame: Within 10 weeks post-oocyte retrieval ]
    Frequency of subjects with biochemical abortions within 10 weeks post-oocyte retrieval will be presented.

  5. Positive β-hCG rate at 2 weeks and 2 weeks + 3-4 Days post oocyte retrieval [ Time Frame: At 2 weeks and 2 weeks + 3-4 Days post oocyte retrieval ]

    Frequency of subjects with positive β-hCG rate at 2 weeks and 2 weeks + 3-4 Days will be presented.

    Positive β-hCG is defined as a positive serum β-hCG test at 2 weeks and 2 weeks + 3-4 Days post-oocyte retrieval.


  6. Clinical pregnancy rate at 6 weeks [ Time Frame: At 6 weeks post-oocyte retrieval ]
    Frequency of subjects with clinical pregnancy at 6 weeks will be presented. Clinical pregnancy is defined as a TVUS showing at least 1 intrauterine gestational sac with fetal heart beat at 6 weeks post-oocyte retrieval.

  7. Clinical pregnancy rate at 10 weeks [ Time Frame: At 10 weeks post-oocyte retrieval ]
    Frequency of subjects with clinical pregnancy at 10 weeks will be presented.

  8. Rate of ectopic and heterotopic pregnancies following oocyte retrieval [ Time Frame: At 4 weeks + 3-4 Days, 6 weeks, and 10 weeks after oocyte retrieval ]
    Frequency of subjects with ectopic and heterotopic pregnancies will be presented.

  9. Rate of abnormal findings in clinical laboratory tests and vital signs [ Time Frame: From screening till 12 weeks ]
    Frequency of subjects with abnormal findings in clinical laboratory tests or vital signs will be presented.

  10. Frequency, intensity/grade, seriousness, and relatedness of adverse events (AEs) [ Time Frame: From screening till 12 weeks ]

    The frequency of total AEs will be presented as well as the frequency of AEs by categories of intensity (mild, moderate, severe) and the frequency of related AEs.

    An AE is any untoward medical occurrence in a subject participating in a clinical trial.

    The intensity of an AE would be classified using the following 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity [disturbing]) or severe (inability to work or perform usual activities [unacceptable]).

    The possibility of whether the investigational medicinal product caused the AE would be classified as one of the following: reasonable possibility, no reasonable possibility.


  11. Frequency and intensity/grade of vaginal bleeding/spotting [ Time Frame: At 4 weeks post-oocyte retrieval till 12 weeks ]
    Frequency of vaginal bleeding/spotting will be presented in total and by categories of intensity/grade.

  12. Frequency and intensity/grade of vaginal hemorrhage [ Time Frame: At 4 weeks post-oocyte retrieval till 12 weeks ]
    Frequency of vaginal hemorrhage will be presented in total and by categories of intensity/grade. Vaginal hemorrhage is defined as a) blood loss of greater than 500 mL based on the opinion of the Investigator or b) hemoglobin post-treatment lesser than 10 gm/dL or c) blood loss requiring transfusion.

  13. Frequency and intensity/grade of pain [ Time Frame: From screening till 12 weeks ]
    Frequency of pain will be presented in total and by categories of intensity/grade.

  14. Frequency and intensity/grade of vaginal infection [ Time Frame: From screening till 12 weeks ]
    Frequency of vaginal infection will be presented in total and by categories of intensity/grade.

  15. Frequency and intensity/grade of vaginal irritation [ Time Frame: From screening till 12 weeks ]
    Frequency of vaginal irritation will be presented in total and by categories of intensity/grade.

  16. Frequency, intensity/grade, seriousness, and relatedness of AEs associated with vaginal and cervical abrasions and lesions [ Time Frame: At screening, on Day 1 of PVR treatment, and at 4 weeks + 3-4 Days, 6, 10, and 12 weeks ]
    Frequency, intensity/grade, seriousness, and relatedness of AEs associated with vaginal and cervical abrasions and lesions will be presented.

  17. Frequency, intensity/grade, seriousness, and relatedness of AEs associated with vaginal adhesions [ Time Frame: At screening, on Day 1 of PVR treatment, and at 4 weeks + 3-4 Days, 6, 10, and 12 weeks ]
    Frequency, intensity/grade, seriousness, and relatedness of AEs associated with vaginal adhesions will be presented.

  18. Frequency and reason for PVR discontinuation [ Time Frame: From screening till 12 weeks ]
    Frequency of subjects who prematurely discontinued PVR will be presented in total and by reason.



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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pre-menopausal females aged 18-34 years.
Accepts Healthy Volunteers:   No
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 subjects 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565211


Locations
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United States, Arizona
Fertility Treatment Center
Tempe, Arizona, United States, 85284
United States, California
HRC Fertility
Encino, California, United States, 91436
United States, Delaware
Reproductive Associates of DE
Newark, Delaware, United States, 19713
United States, Florida
Women's Medical Research Group
Clearwater, Florida, United States, 33759
Center for Reproductive Medicine
Winter Park, Florida, United States, 32789
United States, Idaho
Idaho Center for Reproductive Medicine
Boise, Idaho, United States, 83702
United States, Illinois
InVia Fertility
Hoffman Estates, Illinois, United States, 60169
United States, North Carolina
Carolina Conceptions
Raleigh, North Carolina, United States, 27607
United States, Pennsylvania
Abington Reproductive Medicine
Abington, Pennsylvania, United States, 19046
Main Line Fertility Center
Bryn Mawr, Pennsylvania, United States, 19010
United States, Texas
Center for Assisted Reproduction
Bedford, Texas, United States, 76022
Houston Fertility Institute
Houston, Texas, United States, 77063
Center of Reproductive Medicine
Webster, Texas, United States, 77598
United States, Utah
Utah Fertility Center
Pleasant Grove, Utah, United States, 84062
United States, Virginia
Eastern Virginia Medical School | EVMS Obstetrics & Gynecology
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Global Clinical Compliance Ferring Pharmaceuticals

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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03565211     History of Changes
Other Study ID Numbers: 000293
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ferring Pharmaceuticals:
Progesterone vaginal ring (PVR)
Vaginal progesterone ring
Assisted reproductive technology (ART)
Infertility

Additional relevant MeSH terms:
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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs