Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04163640
• Other study ID #: RMA-2019-05
• Status: Completed
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: July 21, 2023

Study information

• Verified date: September 2023
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 21, 2023
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Menopause, Premature
• Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

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

Locations

Country	Name	City	State
Turkey	Acibadem University	Istanbul
United States	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Countries where clinical trial is conducted

United States,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	number of mature oocytes retrieved- POR group	the total number of mature oocytes retrieved	24 hours post egg retrieval procedure