Infertility, Female, Ovarian Failure
Conditions
Brief summary
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
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.
Interventions
OTHERintra-ovarian platelet rich plasma injection
patients will undergo a transvaginal intra-ovarian platelet rich plasma injection
Sponsors
Reproductive Medicine Associates of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
1. POI according to ESHRE criteria (patient must fit both criteria): 1. presence of menstrual disturbance defined as oligo/amenorrhea for at least 4 months 2. biochemical confirmation as evidenced by an elevated FSH level \>25 IU/L on two occasions \> 4 weeks apart 2. 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) 3. Patients declining ovum donation treatment
Exclusion criteria
1. Age \<18yo or \>38yrs 2. Autoimmune or sex chromosome etiology of POI 3. Ongoing malignancy 4. Previous ovarian surgery 5. Previous gonadotoxic treatment 6. Anticoagulant use for which plasma infusion is contraindicated 7. FMR1 mutations 8. If the duration of the amenorrhea is more than 2 years, patients are discouraged to participate, although it is not an exclusion criterion. 9. Patients with only 1 ovary 10. BMI \> 35 11. Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable) 12. Surgically obtained sperm 13. Presence of hydrosalpinges that communicate with endometrial cavity 14. Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis 15. Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid 16. Use of a gestational carrier 17. Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation 18. Known ovaries that are not accessible transvaginally. 19. Ovarian endometrioma(s) or dermoid cyst(s) identified via transvaginal ultrasound 20. FSH \> 40iu/l
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of participants with a mature oocyte retrieved- POI group | 24 hours post egg retrieval procedure | success or failure is determined by the retrieval of at least one mature oocyte |
| number of mature oocytes retrieved- POR group | 24 hours post egg retrieval procedure | the total number of mature oocytes retrieved |
Countries
Turkey (Türkiye), United States
Outcome results
None listed