Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response
Completed · Not applicable
Conditions studied: Ovarian Failure, Infertility, Female
In brief
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.
Key facts
- Study ID
- NCT04163640
- Run by
- Reproductive Medicine Associates of New Jersey
- People needed
- 90
- Starts
- 2020-02-24
- Expected to finish
- 2023-07-21
- Last updated by the study team
- 2023-09-15
Who can join
Age: 18 and older, up to 38. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Reproductive Medicine Associates of New Jersey — Basking Ridge, New Jersey, United States
- Acibadem University — Istanbul, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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