CompletedNot Applicable

Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

United States, Turkey (Türkiye)90 participantsStarted 2020-02-24

Plain-language 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.

Who can participate

Age range18 Years – 38 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

number of participants with a mature oocyte retrieved- POI group

Timeframe: 24 hours post egg retrieval procedure

number of mature oocytes retrieved- POR group

Timeframe: 24 hours post egg retrieval procedure

Trial details

NCT IDNCT04163640

SponsorReproductive Medicine Associates of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-05

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