Infertility, Infertility, Female, Infertility Unexplained, Menopause, Menopause, Premature, Menopause Premature Asymptomatic, Menopause Premature Symptomatic, Menopause Related Conditions, Perimenopausal Disorder, Premature Ovarian Failure, Premature Ovarian Failure 1, Premature Ovarian Failure 2A, Premature Ovarian Failure 3, Premature Ovarian Failure 4, Premature Ovarian Failure 5, Premature Ovarian Failure 6, Premature Ovarian Failure 7, Premature Ovarian Failure 8, Premature Ovarian Failure 9, Premature Ovarian Failure, Familial
Conditions
Keywords
Infertility, Pregnancy, Menopause, Perimenopause, Premature Ovarian Failure
Brief summary
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.
Detailed 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).
Interventions
OTHERAutologous PRP injection into human ovarian tissue
Using FDA-approved equipment, blood plasma is received from participant, isolated/enriched into PRP, and infused into the ovaries under transvaginal ultrasound guidance.
Sponsors
Ascendance Biomedical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A study group receives the intervention, which is compared in terms of efficacy against a matched group of control patients.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive IVF | 12 months | Following the initial Ovarian Rejuvenation Treatment, subjects will undergo IVF treatment to test the efficacy of the Protocol for fertility outcomes, as per trial protocols. |
| Positive Pregnancy and Conception | 12 months | Following completion of trial protocols, patients will conduct ongoing post-treatment follow-up with trial staff for recording progress of all ongoing pregnancies and conceptions, via post-treatment correspondence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Egg Quality | 12 months | Using Pre-Implantation Genetic Screening, the trials will study the changes to egg quality of all eggs generated as a result of the treatment. A comparison group of patients who have received standard IVF treatment without the Inovium Ovarian Rejuvenation Treatment will be used to study this outcome. |
| Changes in Health Outcomes | 12 months | Changes in overall health levels will be studied. A comparison group of patients who have received standard IVF treatment without the Inovium Ovarian Rejuvenation Treatment will be used to study this outcome. All patient data collected as described in the other outcomes will be used in this comparison. |
| Resumption of Menses | 12 months | With Premature Ovarian Failure and natural menopause the normal menstrual cycle is disrupted and normal menses does not occur. Patients will monitor for resumption of menses. |
| Changes in Menopausal Symptoms | 12 months | A before-and-after questionnaire will be administered to collect patient personal experience data regarding changes in menopausal symptoms. |
| Duration of Identified Benefits of Treatment | 12 months | The duration of effects will be studied, in order to identify a frequency of treatment necessary to sustain positive health and fertility outcomes. |
| Changes in Hormone Levels | 12 months | Changes in hormonal levels toward normal ranges. Hormones may include FSH/LH; Estradiol/ progesterone;Inhibin; Anti- Mullerian Hormone |
Countries
United States
Outcome results
None listed