Inovium Ovarian Rejuvenation Trials

Ascendance Biomedical

Status and phase: Completed; Phase 1

Conditions: Menopause, Premature; Premature Ovarian Failure 5; Menopause; Premature Ovarian Failure 8; Menopause Premature Asymptomatic; Menopause Premature Symptomatic; Premature Ovarian Failure 1; Premature Ovarian Failure 6; Premature Ovarian Failure 7; Premature Ovarian Failure 2A; Infertility, Female; Premature Ovarian Failure; Infertility Unexplained; Menopause Related Conditions; Infertility; Perimenopausal Disorder; Premature Ovarian Failure 3; Premature Ovarian Failure 9; Premature Ovarian Failure, Familial; Premature Ovarian Failure 4

Treatments: Other: Autologous PRP injection into human ovarian tissue

Study type: Interventional

Funder types: Industry

Identifiers

NCT03178695

882388

Details and patient eligibility

About

The Inovium Ovarian Rejuvenation Treatment is a PRP-based autologous treatment used in combination with a stimulated IVF sequence and Pre-Implantation Genetic Screening to treat infertility in women experiencing menopause, perimenopause, and premature ovarian failure.

Full description

This research extends earlier work conducted by Inovium associates in Athens, Greece who demonstrated efficacy of intraovarian injection of autologous PRP for resumption of menses, hormone stabilization, and conception after IVF in multiple women following PRP+natural cycle IVF (i.e., without gonadotropin stimulation). The use of stimulation (gonadotropins) and targeted pre- and posttreatment hormone monitoring during this clinical trial aims to characterize more fully the transition from PRP dosing, embryogenesis, IVF and conception.

The current study seeks to describe how PRP works to rejuvenate immune system and ovarian stem cells, restore menses, provide hormone stability, and generate successful IVF sequences and conceptions. The quality of all embryos generated will be studied via PGS, with the goal of generating euploid embryos. Hormone stability and biomarkers of aging will also be evaluated to understand the extent of any observed benefits, and to estimate how long such effects may be sustained with a single PRP treatment.

Autologous activated PRP used in this clinical study is isolated from patient derived (blood) samples collected on-site, using FDA-approved Regenlab [Lausanne, Switzerland] BCT-1 PRP Kit and RegenLab Drucker Centrifuge (FDA 510(k)-Approval #BK110061; ISO#13485).

Enrollment: 200 patients

Sex: Female

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent
• Women over the age of 35
• Primary or secondary amenorrhea at least for 3-6 months
• Presence of at least one ovary
• Agree to report any pregnancy to the research staff immediately.
• Willing and able to comply with study requirements.
• Willing to receive IVF to get pregnant as part of the experimental protocol.

Exclusion criteria

• Men will be excluded from the study.
• Current or previous IgA deficiency
• Current or previous premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality
• Current or previous great injuries or adhesions to the pelvis or ovaries
• Current and ongoing pregnancy
• Current and ongoing anticoagulant use for which plasma infusion appears contraindicated
• Current and ongoing major Mental health disorder that precludes participation in the study
• Current and ongoing active substance abuse or dependence
• Current and ongoing gynecological or non-gynecological cancer
• Current and ongoing chronic pelvic pain

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Treatment Group

Experimental group

Description:

PRP is freshly isolated from patients with diminished ovarian reserve as determined by at least one prior IVF cycle canceled for poor follicular recruitment response, or estimated by serum AMH and/or FSH, no menses for ≥1 year. Immediately following substrate isolation and activation with calcium gluconate, approximately 5 mL of autologous PRP is injected into each ovary under direct transvaginal sonogram guidance. AMH, FSH, and serum estradiol data will be recorded at 2wk intervals post-PRP and compared to baseline (pre-PRP) values.

Treatment:

Other: Autologous PRP injection into human ovarian tissue

Comparison Group

No Intervention group

Description:

Data collected from all patients in the Treatment Group will be compared to a dataset compiled from 25 - 50 women of similar age having received like treatment via IVF and gonadotropin stimulation for positive fertility outcomes in past clinical work at the Center for Advanced Genetics, as a comparison model and substitute control group. The purpose of this comparison will be to determine overall efficacy of the Inovium Ovarian Rejuvenation Treatment as separated from the standard efficacy rates of CAG-established IVF processes and gonadotropins used in the trial.