Premature Ovarian InsufficiencyOPIFNCT05279560
Ovarian PRP (Platelet Rich Plasma) Injection for Follicular Activation
A study testing autologous PRP (platelet rich plasma) and Saline solution (NaCL) Injection in people with Premature Ovarian Insufficiency and Infertility, Female, run by University of Luebeck at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency, Infertility, Female, Sterility, Female
- What is being tested?
- autologous PRP (platelet rich plasma) and Saline solution (NaCL) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteGermany
- Study dates
- 17 Mar 2022to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Serum AMH < 0.5 ng/ml (at screening visit and in the absence of OC or sex-steroid intake)
- Antral follicular count (AFC) in both ovaries ≤ 5 (at screening visit and in the absence of OC or sex-steroid intake)
- Spontaneous cycle, menstrual cycle length 21-35 days
- Body mass index (BMI) ≥18 kg/m2 and ≤38 kg/m2
- Both ovaries must be visible by transvaginal ultrasound examination
- Both ovaries must be judged accessible by transvaginal puncture
Show all 10Show fewer
- Indication for IVF or ICSI treatment
- Willingness to participate and provide written consent prior to initiation of any study-related procedures
- The subject and male partner must agree to participate in the infant follow-up if she becomes pregnant
- The subject must be able to communicate well with the investigator and research staff and to comply with the requirements of the study protocol.
Who cannot join
- ≥ four cumulus-oocyte-complexes (COCs) retrieved in a previous IVF cycles with a conventional stimulation protocol (within 6 months before enrollment)
- Serum value of FSH ≥25 IU/l (within 12 months measured in the absence of OC or hormone replacement intake)
- Thrombocytopenia defined as < 100.000 platelets/µl at screening
- Oral contraceptive or sex steroid intake within 1 month prior to enrollment
- Presence of structural or numerical chromosomal abnormality in cytogenetic analysis
- Relevant autoimmune disease
Show all 16Show fewer
- History of malignancy and systemic chemotherapy or pelvic radiation
- Severe endometriosis (stage III-IV)
- Ovaries located outside the inner pelvis
- Presence of unilateral or bilateral hydrosalpinx
- Relevant endocrine disorders such as hypothalamic-pituitary disorder or thyroid dysfunction (except substituted Hashimoto's thyroiditis or latent hypothyroidism)
- Relevant thrombophilic disorder
- Contraindication for pregnancy
- Contraindication for transvaginal ovarian puncture (such as previous major lower abdominal surgery and known severe pelvic adhesion)
- Uterine malformations or pathologies (such as sub mucosal fibroid(s), endometrial hyperplasia, endometrial fluid accumulation, or endometrial adhesions)
- Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subjects in or to complete the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Intra-ovarian PRP Injection Within a Prospective, Single-blinded, Placebo-controlled, Randomized, Clinical Superiority Trial in Subjects With Low Ovarian Reserve/Expected Poor Ovarian Response
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.
Read the detailed description
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.
- Being tested
- autologous PRP (platelet rich plasma), Saline solution (NaCL) Injection
- Keywords
- poor ovarian response, low ovarian response, ICSI, IVF, ART, Platelet rich plasma, PRP
- Medical subject headings
- Primary Ovarian Insufficiency, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous PRP (platelet rich plasma)Biological
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.
Saline solution (NaCL) InjectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Autologous intra-ovarian PRP injection | Experimental | Study group, treated with autologous intra-ovarian PRP injection and undergoing a subsequent fresh ET-IVF/ICSI cycle in the third cycle after intervention Receives: Biological: autologous PRP (platelet rich plasma) |
| intra-ovarian saline solution (NaCL) injection | Placebo comparator | Control group, treated with intra-ovarian NaCl injection and undergoing a subsequent fresh ET-IVF/ICSI cycle in the third cycle after intervention Receives: Other: Saline solution (NaCL) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian response
Number of retrieved COCs per intention-to-treat
Measured: 34-36 hours following hCG administration at the end of ovarian stimulation
Secondary outcomes (20)
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)
Measured: 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)
Measured: 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
Measured: Day 0 after follicle puncture
Number of 2PN oocytes
Mean number per protocol
Measured: Day 1 after follicle puncture
Mean number and quality of embryos
Grade a for cleavage stage embryo, >=3BB for blastocyst
Measured: Day 2-5 after follicle puncture
Biochemical pregnancy rate
Incidence of serum beta-hCG test > 25 mIU/ml per ITT and PP
Measured: 12-16 days after oocyte pick-up
Clinical pregnancy rate
Incidence of gestational sac with heartbeat assessed by TVS per ITT and PP
Measured: 4 weeks after embryo transfer
Ongoing pregnancy rate
Incidence of at least one foetus with heart beat assessed by TVS
Measured: 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
Measured: 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
Measured: after 22 weeks of gestation
Live birth rate
Incidence of the birth of at least one live newborn after 22 weeks of gestation
Measured: at a follow-up time of 30 days after delivery
Gestational age
Gestational week estimated by calculating days from oocyte retrieval + 14 days
Measured: at the day of delivery
Weight of newborn
Birth weight measured in gram
Measured: at the day of delivery
Length of newborn
Birth length measured in centimeter
Measured: at the day of delivery
Incidence of birth sex
Incidence of female or male newborn
Measured: at the day of delivery
Incidence of multiple birth
Incidence of singleton/multiple newborns
Measured: at the day of delivery
Neonatal health
major and minor congenital anomalies
Measured: 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)
Measured: 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".
Measured: 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
Measured: at a follow-up time after 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start17 Mar 2022
- Primary completion30 Apr 2025
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. M.Sc. Georg Griesinger, University of Luebeck
- Investigators
- Georg Griesing, MD, Principal investigator, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279560
- Sponsor's protocol ID
- Aktenzeichen 21-348
- Acronym
- OPIF
- Status last verified
- May 2025
- First submitted
- 16 Jan 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon reasonable request.
Publications
Gougeon A, Ecochard R, Thalabard JC. Age-related changes of the population of human ovarian follicles: increase in the disappearance rate of non-growing and early-growing follicles in aging women. Biol Reprod. 1994 Mar;50(3):653-63. doi: 10.1095/biolreprod50.3.653.
PubMed 8167237Martin JJ, Woods DC, Tilly JL. Implications and Current Limitations of Oogenesis from Female Germline or Oogonial Stem Cells in Adult Mammalian Ovaries. Cells. 2019 Jan 28;8(2):93. doi: 10.3390/cells8020093.
PubMed 30696098Maleki-Hajiagha A, Razavi M, Rouholamin S, Rezaeinejad M, Maroufizadeh S, Sepidarkish M. Intrauterine infusion of autologous platelet-rich plasma in women undergoing assisted reproduction: A systematic review and meta-analysis. J Reprod Immunol. 2020 Feb;137:103078. doi: 10.1016/j.jri.2019.103078. Epub 2019 Dec 31.
PubMed 32006776Sills ES, Rickers NS, Li X, Palermo GD. First data on in vitro fertilization and blastocyst formation after intraovarian injection of calcium gluconate-activated autologous platelet rich plasma. Gynecol Endocrinol. 2018 Sep;34(9):756-760. doi: 10.1080/09513590.2018.1445219. Epub 2018 Feb 28.
PubMed 29486615Danforth DR, Arbogast LK, Ghosh S, Dickerman A, Rofagha R, Friedman CI. Vascular endothelial growth factor stimulates preantral follicle growth in the rat ovary. Biol Reprod. 2003 May;68(5):1736-41. doi: 10.1095/biolreprod.101.000679. Epub 2002 Dec 11.
PubMed 12606430Quintana R, Kopcow L, Sueldo C, Marconi G, Rueda NG, Baranao RI. Direct injection of vascular endothelial growth factor into the ovary of mice promotes follicular development. Fertil Steril. 2004 Oct;82 Suppl 3:1101-5. doi: 10.1016/j.fertnstert.2004.03.036.
PubMed 15474081Bakacak M, Bostanci MS, Inanc F, Yaylali A, Serin S, Attar R, Yildirim G, Yildirim OK. Protective Effect of Platelet Rich Plasma on Experimental Ischemia/Reperfusion Injury in Rat Ovary. Gynecol Obstet Invest. 2016;81(3):225-31. doi: 10.1159/000440617. Epub 2015 Oct 24.
PubMed 26496072Ozcan P, Takmaz T, Tok OE, Islek S, Yigit EN, Ficicioglu C. The protective effect of platelet-rich plasma administrated on ovarian function in female rats with Cy-induced ovarian damage. J Assist Reprod Genet. 2020 Apr;37(4):865-873. doi: 10.1007/s10815-020-01689-7. Epub 2020 Feb 4.
PubMed 32020412Atkinson L, Martin F, Sturmey RG. Intraovarian injection of platelet-rich plasma in assisted reproduction: too much too soon? Hum Reprod. 2021 Jun 18;36(7):1737-1750. doi: 10.1093/humrep/deab106.
PubMed 33963408Melo P, Navarro C, Jones C, Coward K, Coleman L. The use of autologous platelet-rich plasma (PRP) versus no intervention in women with low ovarian reserve undergoing fertility treatment: a non-randomized interventional study. J Assist Reprod Genet. 2020 Apr;37(4):855-863. doi: 10.1007/s10815-020-01710-z. Epub 2020 Feb 7.
PubMed 32030554Urman B, Boza A, Balaban B. Platelet-rich plasma another add-on treatment getting out of hand? How can clinicians preserve the best interest of their patients? Hum Reprod. 2019 Nov 1;34(11):2099-2103. doi: 10.1093/humrep/dez190.
PubMed 31725883Farimani M, Heshmati S, Poorolajal J, Bahmanzadeh M. A report on three live births in women with poor ovarian response following intra-ovarian injection of platelet-rich plasma (PRP). Mol Biol Rep. 2019 Apr;46(2):1611-1616. doi: 10.1007/s11033-019-04609-w. Epub 2019 Feb 5.
PubMed 30725347Sills ES, Wood SH. Autologous activated platelet-rich plasma injection into adult human ovary tissue: molecular mechanism, analysis, and discussion of reproductive response. Biosci Rep. 2019 Jun 4;39(6):BSR20190805. doi: 10.1042/BSR20190805. Print 2019 Jun 28.
PubMed 31092698Hsu CC, Hsu L, Hsu I, Chiu YJ, Dorjee S. Live Birth in Woman With Premature Ovarian Insufficiency Receiving Ovarian Administration of Platelet-Rich Plasma (PRP) in Combination With Gonadotropin: A Case Report. Front Endocrinol (Lausanne). 2020 Feb 19;11:50. doi: 10.3389/fendo.2020.00050. eCollection 2020.
PubMed 32140135
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Intra-ovarian PRP Injection Within a Prospective, Single-blinded, Placebo-controlled, Randomized, Clinical Superiority Trial in Subjects With Low Ovarian Reserve/Expected Poor Ovarian Response
- ClinicalTrials.gov ID
- NCT05279560
- Acronym / sponsor ID
- OPIF / Aktenzeichen 21-348
- Keywords
- poor ovarian response, low ovarian response, ICSI, IVF, ART, Platelet rich plasma, PRP
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous intra-ovarian PRP injection | Experimental | Biological: autologous PRP (platelet rich plasma)Study group, treated with autologous intra-ovarian PRP injection and undergoing a subsequent fresh ET-IVF/ICSI cycle in the third cycle after intervention |
| intra-ovarian saline solution (NaCL) injection | Placebo comparator | Other: Saline solution (NaCL) InjectionControl group, treated with intra-ovarian NaCl injection and undergoing a subsequent fresh ET-IVF/ICSI cycle in the third cycle after intervention |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Serum AMH < 0.5 ng/ml (at screening visit and in the absence of OC or sex-steroid intake)
- Antral follicular count (AFC) in both ovaries ≤ 5 (at screening visit and in the absence of OC or sex-steroid intake)
- Spontaneous cycle, menstrual cycle length 21-35 days
- Body mass index (BMI) ≥18 kg/m2 and ≤38 kg/m2
- Both ovaries must be visible by transvaginal ultrasound examination
Key exclusion criteria (16 listed)
- ≥ four cumulus-oocyte-complexes (COCs) retrieved in a previous IVF cycles with a conventional stimulation protocol (within 6 months before enrollment)
- Serum value of FSH ≥25 IU/l (within 12 months measured in the absence of OC or hormone replacement intake)
- Thrombocytopenia defined as < 100.000 platelets/µl at screening
- Oral contraceptive or sex steroid intake within 1 month prior to enrollment
- Presence of structural or numerical chromosomal abnormality in cytogenetic analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous PRP (platelet rich plasma)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. | Biological | Autologous intra-ovarian PRP injection |
| Saline solution (NaCL) InjectionInjecting 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. | Other | intra-ovarian saline solution (NaCL) injection |
Primary outcome
Ovarian response
Time frame: 34-36 hours following hCG administration at the end of ovarian stimulation
Number of retrieved COCs per intention-to-treat
20 secondary outcomes
Hormone levels
Time frame: Follow-up period of three months entailing monthly evaluation
Follicular response
Time frame: On the day of triggering of final oocyte maturation or the day before
COCs and MII oocytes
Time frame: Day 0 after follicle puncture
Number of 2PN oocytes
Time frame: Day 1 after follicle puncture
Mean number and quality of embryos
Time frame: Day 2-5 after follicle puncture
Biochemical pregnancy rate
Time frame: 12-16 days after oocyte pick-up
Clinical pregnancy rate
Time frame: 4 weeks after embryo transfer
Ongoing pregnancy rate
Time frame: 8-10 weeks after embryo transfer
Miscarriage rate
Time frame: early (week 7-12 weeks of gestation); late (between 12 to 22 weeks of gestation)
Still birth rate
Time frame: after 22 weeks of gestation
Live birth rate
Time frame: at a follow-up time of 30 days after delivery
Gestational age
Time frame: at the day of delivery
Weight of newborn
Time frame: at the day of delivery
Length of newborn
Time frame: at the day of delivery
Incidence of birth sex
Time frame: at the day of delivery
Incidence of multiple birth
Time frame: at the day of delivery
Neonatal health
Time frame: at a follow-up time of 30 days after delivery
Post procedure pain
Time frame: on the day of follicle puncture
Fertility Quality of Life Questionnaire
Time frame: on the day of follicle puncture and embryo transfer
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: at a follow-up time after 1, 2 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 8167237Gougeon A, Ecochard R, Thalabard JC. Age-related changes of the population of human ovarian follicles: increase in the disappearance rate of non-growing and early-growing follicles in aging women. Biol Reprod. 1994 Mar;50(3):653-63. doi: 10.1095/biolreprod50.3.653.
- Background: PubMed 30696098Martin JJ, Woods DC, Tilly JL. Implications and Current Limitations of Oogenesis from Female Germline or Oogonial Stem Cells in Adult Mammalian Ovaries. Cells. 2019 Jan 28;8(2):93. doi: 10.3390/cells8020093.
- Background: PubMed 32006776Maleki-Hajiagha A, Razavi M, Rouholamin S, Rezaeinejad M, Maroufizadeh S, Sepidarkish M. Intrauterine infusion of autologous platelet-rich plasma in women undergoing assisted reproduction: A systematic review and meta-analysis. J Reprod Immunol. 2020 Feb;137:103078. doi: 10.1016/j.jri.2019.103078. Epub 2019 Dec 31.
- Background: PubMed 29486615Sills ES, Rickers NS, Li X, Palermo GD. First data on in vitro fertilization and blastocyst formation after intraovarian injection of calcium gluconate-activated autologous platelet rich plasma. Gynecol Endocrinol. 2018 Sep;34(9):756-760. doi: 10.1080/09513590.2018.1445219. Epub 2018 Feb 28.
- Background: PubMed 12606430Danforth DR, Arbogast LK, Ghosh S, Dickerman A, Rofagha R, Friedman CI. Vascular endothelial growth factor stimulates preantral follicle growth in the rat ovary. Biol Reprod. 2003 May;68(5):1736-41. doi: 10.1095/biolreprod.101.000679. Epub 2002 Dec 11.
- Background: PubMed 15474081Quintana R, Kopcow L, Sueldo C, Marconi G, Rueda NG, Baranao RI. Direct injection of vascular endothelial growth factor into the ovary of mice promotes follicular development. Fertil Steril. 2004 Oct;82 Suppl 3:1101-5. doi: 10.1016/j.fertnstert.2004.03.036.
- Background: PubMed 26496072Bakacak M, Bostanci MS, Inanc F, Yaylali A, Serin S, Attar R, Yildirim G, Yildirim OK. Protective Effect of Platelet Rich Plasma on Experimental Ischemia/Reperfusion Injury in Rat Ovary. Gynecol Obstet Invest. 2016;81(3):225-31. doi: 10.1159/000440617. Epub 2015 Oct 24.
- Background: PubMed 32020412Ozcan P, Takmaz T, Tok OE, Islek S, Yigit EN, Ficicioglu C. The protective effect of platelet-rich plasma administrated on ovarian function in female rats with Cy-induced ovarian damage. J Assist Reprod Genet. 2020 Apr;37(4):865-873. doi: 10.1007/s10815-020-01689-7. Epub 2020 Feb 4.
- Background: PubMed 33963408Atkinson L, Martin F, Sturmey RG. Intraovarian injection of platelet-rich plasma in assisted reproduction: too much too soon? Hum Reprod. 2021 Jun 18;36(7):1737-1750. doi: 10.1093/humrep/deab106.
- Background: PubMed 32030554Melo P, Navarro C, Jones C, Coward K, Coleman L. The use of autologous platelet-rich plasma (PRP) versus no intervention in women with low ovarian reserve undergoing fertility treatment: a non-randomized interventional study. J Assist Reprod Genet. 2020 Apr;37(4):855-863. doi: 10.1007/s10815-020-01710-z. Epub 2020 Feb 7.
- Background: PubMed 31725883Urman B, Boza A, Balaban B. Platelet-rich plasma another add-on treatment getting out of hand? How can clinicians preserve the best interest of their patients? Hum Reprod. 2019 Nov 1;34(11):2099-2103. doi: 10.1093/humrep/dez190.
- Background: PubMed 30725347Farimani M, Heshmati S, Poorolajal J, Bahmanzadeh M. A report on three live births in women with poor ovarian response following intra-ovarian injection of platelet-rich plasma (PRP). Mol Biol Rep. 2019 Apr;46(2):1611-1616. doi: 10.1007/s11033-019-04609-w. Epub 2019 Feb 5.
- Individual participant dataSharing planned: Yes. IPD will be shared upon reasonable request.
Related trials for Premature Ovarian Insufficiency
RecruitingPhase 2
Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
Premature Ovarian Insufficiency, POI
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Not yet recruitingPhase 1
Oral GDC-0077 in Premature Ovarian Insufficiency
Primary Ovarian Insufficiency
RecruitingPhase 3
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
Premature Ovarian Insufficiency
RecruitingObservational study
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Systemic Lupus Erythematosus (Sle), Primary Ovarian Insufficiency (Poi)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Griesing, MD principal investigator
University of Luebeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous PRP (platelet rich plasma) and Saline solution (NaCL) Injection in people with Premature Ovarian Insufficiency and Infertility, Female, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian response (time frame: 34-36 hours following hCG administration at the end of ovarian stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05279560, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.