Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-24

Study Completion Date

2023-07-21

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.

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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.

Conditions

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Ovarian Failure Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

intra-ovarian platelet rich plasma injection

Intervention Type OTHER

patients will undergo a transvaginal intra-ovarian platelet rich plasma injection

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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intra-ovarian platelet rich plasma injection

patients will undergo a transvaginal intra-ovarian platelet rich plasma injection

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No