Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

Study Overview
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Brief Summary
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The objective of this study is to perform a prospective randomized controlled trial seeking to characterize the effects of intra-ovarian injection of platelet rich plasma (PRP) on biomarkers of ovarian reserve as well as IVF outcomes in women with primary ovarian insufficiency (POI) and poor ovarian response (POR) who decline the use of an egg donor to establish a pregnancy.

Detailed Description
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Patients will be randomized to either receive the intra-ovarian PRP injection procedure or not. Regardless of randomization patients will be re-assessed at the same time points for ovarian reserve parameters. If antral follicles are detected at follow up, patients will undergo controlled ovarian hyperstimulation and a routine in vitro fertilization cycle as per protocol.

Official Title
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Ovarian Rejuvenation Through Intra-ovarian Injection of Platelet Rich Plasma for Women With Premature Ovarian Insufficiency (POI) and Poor Ovarian Response (POR)

Conditions
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Ovarian Failure, Infertility, Female

Intervention / Treatment
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* Other: intra-ovarian platelet rich plasma injection


Participation Criteria
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Eligibility Criteria
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Inclusion criteria POI according to ESHRE criteria (patient must fit both criteria): presence of menstrual disturbance defined as oligo/amenorrhea for at least 4 months biochemical confirmation as evidenced by an elevated FSH level >25 IU/L on two occasions > 4 weeks apart POR defined by at least two prior cycles with POR (≤3 oocytes retrieved with a conventional stimulation protocol, or a cancelled cycle due to poor response) Patients declining ovum donation treatment Exclusion criteria Age <18yo or >38yrs Autoimmune or sex chromosome etiology of POI Ongoing malignancy Previous ovarian surgery Previous gonadotoxic treatment Anticoagulant use for which plasma infusion is contraindicated FMR1 mutations If the duration of the amenorrhea is more than 2 years, patients are discouraged to participate, although it is not an exclusion criterion. Patients with only 1 ovary BMI > 35 Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable) Surgically obtained sperm Presence of hydrosalpinges that communicate with endometrial cavity Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid Use of a gestational carrier Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation Known ovaries that are not accessible transvaginally. Ovarian endometrioma(s) or dermoid cyst(s) identified via transvaginal ultrasound FSH > 40iu/l

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Patients randomized to this group will receive the intra-ovarian platelet rich plasma injection | Other: intra-ovarian platelet rich plasma injection<br>* patients will undergo a transvaginal intra-ovarian platelet rich plasma injection<br>|
| No Intervention: Control Group<br>Patients randomized to this group will not receive the intra-ovarian platelet rich plasma injection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with a mature oocyte retrieved- POI group | success or failure is determined by the retrieval of at least one mature oocyte | 24 hours post egg retrieval procedure | 
| number of mature oocytes retrieved- POR group | the total number of mature oocytes retrieved | 24 hours post egg retrieval procedure |