An interventional study of autologous PRP (platelet rich plasma) and Saline solution (NaCL) Injection in Premature Ovarian Insufficiency, Infertility, Female and Sterility, Female, sponsored by University of Luebeck. Active, not recruiting at 1 site in Germany. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by University of Luebeck · Not applicable, Interventional, and Treatment
The primary objective is to investigate the efficacy, defined as an increase in oocyte numbers upon ovarian stimulation, and safety of a single intra-ovarian PRP injection vs. saline solution (NaCl) injection (Placebo) transvaginally or laparoscopically for follicular activation in patients with child wish and with low ovarian reserve/expected poor ovarian response planning to undergo IVF or ICSI using own eggs. Pain score as numerical rating score and validated quality of life questionnaire will be requested after the procedure. Longterm follow-up of all participants will be performed 1, 2 and 5 years after end of study.
Age-related infertility and premature loss of ovarian reserve has become a major challenge for ART professionals as the the average age at first child wish has dramatically increased over time. Under physiological circumstances, most follicles in the human ovary remain dormant throughout the female life span and eventually become atretic, however, histological samples reveal that the follicular pool in the ovary is completely exhausted only as late as the early 70ies and that the ovary holds oogonial stem cells, which may have the ability to differentiate into functional follicles. The pressing problem for reproductive medicine is therefore the question how to reactivate some of the putative ovarian 'reproductive reserve' in those women with premature follicular depletion or those who wish to become pregnant at advanced age.
Platelet rich plasma (PRP) is a blood-derived product, characterized by high concentrations of growth factors and chemokines. PRP is produced by centrifuging a small quantity of the patient's own blood and extracting the active, platelet-rich fraction. The platelet-rich fraction is applied to the human body typically by injection. PRP is used for therapeutic purposes in different medical areas ranging from orthopedics to plastic surgery, for its putative ability to stimulate and facilitate cell proliferation and thereby tissue differentiation and regeneration.
In the context of reproductive medicine, PRP has been proposed to increase pregnancy rates after uterine flushing in women with recurrent implantation failure or thin endometrium. Intra-ovarian injection of PRP has been proposed to activate dormant ovarian follicles pre IVF-treatment in cases of idiopathic low ovarian reserve, premature ovarian insufficiency or ovarian depletion because of advanced maternal age. To date, there is no randomized placebo-controlled trial available that has evaluated intra-ovarian PRP injection in terms of efficacy and safety for premature ovarian failure, and, more specifically, also not in patients with depleted ovarian reserve/poor ovarian response (POR) who constitute a significant proportion of patients undergoing assisted reproduction.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 114 is close to the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →University of Luebeck is the lead sponsor of 74 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Study group, treated with autologous intra-ovarian PRP injection and undergoing a subsequent fresh ET-IVF/ICSI cycle in the third cycle after intervention
Biological: autologous PRP (platelet rich plasma)
Control group, treated with intra-ovarian NaCl injection and undergoing a subsequent fresh ET-IVF/ICSI cycle in the third cycle after intervention
Other: Saline solution (NaCL) Injection
The required volume of PRP will be extracted from 60 ml of the patient's peripheral blood. Injecting PRP into the ovaries will be performed likewise to the standard operating procedure of oocyte retrieval. After centrifugation of the whole blood, 5ml PRP will be injected in each ovary intra-medullar and subcortical using a 17-gauge single lumen needle under sedation und under transvaginal ultrasound monitoring.
Injecting NaCL into the ovaries will be performed likewise to the standard operating procedure of oocyte retrieval. NaCL will be injected in each ovary intra-medullar and subcortical using a 17-gauge single lumen needle under sedation und under transvaginal ultrasound monitoring.
Ovarian response
Number of retrieved COCs per intention-to-treat
Time frame: 34-36 hours following hCG administration at the end of ovarian stimulation
Hormone levels
Change from baseline in absolute and relative terms for Anti-Müllerian hormone (AMH), serum follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), testosterone (T) and antral follicle count (AFC)
Time frame: Follow-up period of three months entailing monthly evaluation
Follicular response
Number of follicles (classified and summarised for every ovary as follows: mean diameter 10.0 - 11.9 mm, 12.0 - 13.9 mm, 14.0 - 15.9 mm, 16.0 - 17.9 mm, 18.0 - 19.9 mm and larger 19.9 mm)
Time frame: On the day of triggering of final oocyte maturation or the day before
COCs and MII oocytes
Mean number of retrieved COCs per protocol and mean number of metaphase II (MII) oocytes per protocol
Time frame: Day 0 after follicle puncture
Number of 2PN oocytes
Mean number per protocol
Time frame: Day 1 after follicle puncture
Mean number and quality of embryos
Grade a for cleavage stage embryo, \>=3BB for blastocyst
Time frame: Day 2-5 after follicle puncture
Biochemical pregnancy rate
Incidence of serum beta-hCG test \> 25 mIU/ml per ITT and PP
Time frame: 12-16 days after oocyte pick-up
Clinical pregnancy rate
Incidence of gestational sac with heartbeat assessed by TVS per ITT and PP
Time frame: 4 weeks after embryo transfer
Ongoing pregnancy rate
Incidence of at least one foetus with heart beat assessed by TVS
Time frame: 8-10 weeks after embryo transfer
Miscarriage rate
Defined as spontaneous loss of a clinical pregnancy rate, where embryo(s) or fetus(es) is/are nonviable and is/are not spontaneously absorbed or expelled from the uterus or surgically removed
Time frame: early (week 7-12 weeks of gestation); late (between 12 to 22 weeks of gestation)
Still birth rate
Incidence of the delivery of a dead fetus
Time frame: after 22 weeks of gestation
Live birth rate
Incidence of the birth of at least one live newborn after 22 weeks of gestation
Time frame: at a follow-up time of 30 days after delivery
Gestational age
Gestational week estimated by calculating days from oocyte retrieval + 14 days
Time frame: at the day of delivery
Weight of newborn
Birth weight measured in gram
Time frame: at the day of delivery
Length of newborn
Birth length measured in centimeter
Time frame: at the day of delivery
Incidence of birth sex
Incidence of female or male newborn
Time frame: at the day of delivery
Incidence of multiple birth
Incidence of singleton/multiple newborns
Time frame: at the day of delivery
Neonatal health
major and minor congenital anomalies
Time frame: at a follow-up time of 30 days after delivery
Post procedure pain
measured by a numerical rating scale from 0 (no pain) to 10 (worst pain)
Time frame: on the day of follicle puncture
Fertility Quality of Life Questionnaire
FertiQoL International is a validated relational scale to assess the relational domain regarding quality of life in women undergoing infertility treatment. For each question, the patient will check the response that is closest to her current thoughts and feelings. Scale reaches depending on the question from "very dissatisfied" to "very satisfied", "always" to "never" or "an extreme amount" to "not at all".
Time frame: on the day of follicle puncture and embryo transfer
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of adverse and serious adverse events with potential relationship to treatment
Time frame: at a follow-up time after 1, 2 and 5 years
Plan to share: Yes — IPD will be shared upon reasonable request.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Luebeck