Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

Reproductive Medicine Associates of New Jersey

Status: Completed

Conditions: Ovarian Failure; Infertility, Female

Treatments: Other: intra-ovarian platelet rich plasma injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04163640

RMA-2019-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Patients randomized to this group will receive the intra-ovarian platelet rich plasma injection

Treatment:

Other: intra-ovarian platelet rich plasma injection

Control Group

No Intervention group

Description:

Patients randomized to this group will not receive the intra-ovarian platelet rich plasma injection