Premature Ovarian FailureNCT04237909
Effects of Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response and Premature Ovarian Insufficiency
A study testing PRP injection into at least one ovary in people with Premature Ovarian Failure and Diminished Ovarian Reserve, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Reproductive age women diagnosed with poor ovarian response (POR) based on Poseidon criteria and premature ovarian insufficiency (POI) based on ESHRE criteria and with a history of at least one prior failed IVF cycle will be recruited for the study. Read more about this study
- Who is it for?
- Ages 20 to 48 years, women only
- Conditions the study is for
- Premature Ovarian Failure, Diminished Ovarian Reserve
- What is being tested?
- PRP injection into at least one ovary
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2020to 21 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a history of >1 year infertility duration with at least one ovary, who fulfilled the ESHRE criteria,
- Patients diagnosed with POR based on Poseidon criteria and with a history of at least one prior failed IVF cycle
Who cannot join
- Presence of pregnancy,
- previous diagnosis of any malignancy,
- ovarian insufficiency secondary to sex chromosome etiology,
- prior major lower abdominal surgery resulting in pelvic adhesions,
- anticoagulant use for which plasma infusion is contraindicated,
- current or previous (Immunoglobulin A (IgA) deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intraovarian Injection of Autologous Platelet Rich Plasma on Ovarian Reserve and IVF Outcome Parameters in Women With Premature Ovarian Insufficiency and Poor Ovarian Response
Reproductive age women diagnosed with poor ovarian response (POR) based on Poseidon criteria and premature ovarian insufficiency (POI) based on ESHRE criteria and with a history of at least one prior failed IVF cycle will be recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols and will be injected to at least one ovary. Ovarian reserve parameters and IVF outcomes will be determined.
Read the detailed description
Reproductive age women diagnosed with POR based on Poseidon criteria and POI based on European Society of Human Reproduction and Endocrinology (ESHRE) criteria with a history of at least one prior failed IVF cycle will recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will be determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols. PRP injection will be performed under sedation anesthesia, using a 35 cm 17 G needle under transvaginal ultrasound guidance. On the 2-4th days of the first six menstrual cycles following the procedure, AFC, AMH, and FSH levels will be re-assessed. Patients with at least one antral follicle will be started on ovarian stimulation for in-vitro fertilization- intracytoplasmic sperm injection (IVF-ICSI), followed by embryo banking/ preimplantation genetic testing- aneuploidy (PGT-A) or embryo transfer. Markers of ovarian reserve (AFC, FSH, AMH), and IVF laboratory outcome parameters (number of metaphase II (MII) oocytes, 2PN(pronucleus) embryos, cleavage stage, blastocyst embryos) will be followed.
- Being tested
- PRP injection into at least one ovary
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injection into at least one ovaryBiological
The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into at least one ovary using a 35 cm 17 G single lumen needle. The injection will be done underneath the ovarian cortex to the subcortical and stromal areas. Approximately 2-4cc of the PRP solution will be injected into each ovary. After the procedure, the patients will be taken to the recovery room and will be observed for 30-40 minutes and also be discharged home on the same day.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian Reserve | Experimental | Patients with diminished ovarian reserve or premature ovarian insufficiency Receives: Biological: PRP injection into at least one ovary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian reserve parameters
Number of participants with intraovarian injection of autologous PRP as assessed by blood hormone analysis and ultrasonographic antral follicle counts, change in serum FSH, AMH levels and number of antral follicle counts.
Measured: 6 months
Secondary outcomes (1)
Ovarian response to stimulation
Number of participants with intraovarian injection of autologous PRP as assessed by number antral follicle counts on ultrasound, eggs, and embryos in the laboratory, change from baseline in number of developing follicles, and percentage of obtained eggs and fertilized embryos.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start27 Jan 2020
- Primary completion31 Oct 2020
- Study completion21 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Premature Ovarian FailureStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- After the couples are recruited for the study, Antral follicle count (AFC), serum anti-mullerian hormone (AMH) and follicle stimulating hormone (FSH) levels will be determined at baseline and will be repeated beginning with the first menstrual cycle. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into at least one ovary Ovarian reserve (AFC, FSH, AMH), and IVF laboratory outcome parameters (number of MII oocytes, 2PN embryos, cleavage stage embryos) will be followed for six sequential months. Spontaneous pregnancies will also be recorded.
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulent Tiras, Acibadem University
- Investigators
- Yigit Cakiroglu, Assoc.Prof., Study director, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237909
- Sponsor's protocol ID
- ATADEK 2019/8-18
- Status last verified
- Nov 2020
- First submitted
- 12 Jan 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number); Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.
PubMed 26921622European Society for Human Reproduction and Embryology (ESHRE) Guideline Group on POI; Webber L, Davies M, Anderson R, Bartlett J, Braat D, Cartwright B, Cifkova R, de Muinck Keizer-Schrama S, Hogervorst E, Janse F, Liao L, Vlaisavljevic V, Zillikens C, Vermeulen N. ESHRE Guideline: management of women with premature ovarian insufficiency. Hum Reprod. 2016 May;31(5):926-37. doi: 10.1093/humrep/dew027. Epub 2016 Mar 22.
PubMed 27008889Leijdekkers JA, Eijkemans MJC, van Tilborg TC, Oudshoorn SC, van Golde RJT, Hoek A, Lambalk CB, de Bruin JP, Fleischer K, Mochtar MH, Kuchenbecker WKH, Laven JSE, Mol BWJ, Torrance HL, Broekmans FJM; OPTIMIST study group. Cumulative live birth rates in low-prognosis women. Hum Reprod. 2019 Jun 4;34(6):1030-1041. doi: 10.1093/humrep/dez051.
PubMed 31125412Sills 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 29486615Sfakianoudis K, Simopoulou M, Nitsos N, Lazaros L, Rapani A, Pantou A, Koutsilieris M, Nikas Y, Pantos K. Successful Implantation and Live Birth Following Autologous Platelet-rich Plasma Treatment for a Patient with Recurrent Implantation Failure and Chronic Endometritis. In Vivo. 2019 Mar-Apr;33(2):515-521. doi: 10.21873/invivo.11504.
PubMed 30804135
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraovarian Injection of Autologous Platelet Rich Plasma on Ovarian Reserve and IVF Outcome Parameters in Women With Premature Ovarian Insufficiency and Poor Ovarian Response
- ClinicalTrials.gov ID
- NCT04237909
- Acronym / sponsor ID
- ATADEK 2019/8-18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 21 Nov 2020 (actual)
- First posted
- 23 Jan 2020 (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.
Reproductive age women diagnosed with poor ovarian response (POR) based on Poseidon criteria and premature ovarian insufficiency (POI) based on ESHRE criteria and with a history of at least one prior failed IVF cycle will be recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols and will be injected to at least one ovary. Ovarian reserve parameters and IVF outcomes will be determined.
Detailed description
Reproductive age women diagnosed with POR based on Poseidon criteria and POI based on European Society of Human Reproduction and Endocrinology (ESHRE) criteria with a history of at least one prior failed IVF cycle will recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will be determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols. PRP injection will be performed under sedation anesthesia, using a 35 cm 17 G needle under transvaginal ultrasound guidance. On the 2-4th days of the first six menstrual cycles following the procedure, AFC, AMH, and FSH levels will be re-assessed. Patients with at least one antral follicle will be started on ovarian stimulation for in-vitro fertilization- intracytoplasmic sperm injection (IVF-ICSI), followed by embryo banking/ preimplantation genetic testing- aneuploidy (PGT-A) or embryo transfer. Markers of ovarian reserve (AFC, FSH, AMH), and IVF laboratory outcome parameters (number of metaphase II (MII) oocytes, 2PN(pronucleus) embryos, cleavage stage, blastocyst embryos) will be followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After the couples are recruited for the study, Antral follicle count (AFC), serum anti-mullerian hormone (AMH) and follicle stimulating hormone (FSH) levels will be determined at baseline and will be repeated beginning with the first menstrual cycle. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into at least one ovary Ovarian reserve (AFC, FSH, AMH), and IVF laboratory outcome parameters (number of MII oocytes, 2PN embryos, cleavage stage embryos) will be followed for six sequential months. Spontaneous pregnancies will also be recorded.
| Arm | Type | Receives |
|---|---|---|
| Ovarian Reserve | Experimental | Biological: PRP injection into at least one ovaryPatients with diminished ovarian reserve or premature ovarian insufficiency |
Who may qualify
- Ages
- 20 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with a history of >1 year infertility duration with at least one ovary, who fulfilled the ESHRE criteria,
- Patients diagnosed with POR based on Poseidon criteria and with a history of at least one prior failed IVF cycle
Key exclusion criteria (6 listed)
- Presence of pregnancy,
- previous diagnosis of any malignancy,
- ovarian insufficiency secondary to sex chromosome etiology,
- prior major lower abdominal surgery resulting in pelvic adhesions,
- anticoagulant use for which plasma infusion is contraindicated,
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 |
|---|---|---|
| PRP injection into at least one ovaryThe same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into at least one ovary using a 35 cm 17 G single lumen needle. The injection will be done underneath the ovarian cortex to the subcortical and stromal areas. Approximately 2-4cc of the PRP solution will be injected into each ovary. After the procedure, the patients will be taken to the recovery room and will be observed for 30-40 minutes and also be discharged home on the same day. | Biological | Ovarian Reserve |
Primary outcome
Ovarian reserve parameters
Time frame: 6 months
Number of participants with intraovarian injection of autologous PRP as assessed by blood hormone analysis and ultrasonographic antral follicle counts, change in serum FSH, AMH levels and number of antral follicle counts.
1 secondary outcome
Ovarian response to stimulation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Background: PubMed 26921622Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number); Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.
- Background: PubMed 27008889European Society for Human Reproduction and Embryology (ESHRE) Guideline Group on POI; Webber L, Davies M, Anderson R, Bartlett J, Braat D, Cartwright B, Cifkova R, de Muinck Keizer-Schrama S, Hogervorst E, Janse F, Liao L, Vlaisavljevic V, Zillikens C, Vermeulen N. ESHRE Guideline: management of women with premature ovarian insufficiency. Hum Reprod. 2016 May;31(5):926-37. doi: 10.1093/humrep/dew027. Epub 2016 Mar 22.
- Results publication: PubMed 31125412Leijdekkers JA, Eijkemans MJC, van Tilborg TC, Oudshoorn SC, van Golde RJT, Hoek A, Lambalk CB, de Bruin JP, Fleischer K, Mochtar MH, Kuchenbecker WKH, Laven JSE, Mol BWJ, Torrance HL, Broekmans FJM; OPTIMIST study group. Cumulative live birth rates in low-prognosis women. Hum Reprod. 2019 Jun 4;34(6):1030-1041. doi: 10.1093/humrep/dez051.
- Results publication: 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.
- Results publication: PubMed 30804135Sfakianoudis K, Simopoulou M, Nitsos N, Lazaros L, Rapani A, Pantou A, Koutsilieris M, Nikas Y, Pantos K. Successful Implantation and Live Birth Following Autologous Platelet-rich Plasma Treatment for a Patient with Recurrent Implantation Failure and Chronic Endometritis. In Vivo. 2019 Mar-Apr;33(2):515-521. doi: 10.21873/invivo.11504.
- Individual participant dataSharing planned: No
Related trials for Premature Ovarian Failure
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.
Yigit Cakiroglu, Assoc.Prof. study director
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP injection into at least one ovary in people with Premature Ovarian Failure and Diminished Ovarian Reserve, run by Acibadem University at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 24 Nov 2020. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 reserve parameters (time frame: 6 months). 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 NCT04237909, which also lists 5 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 24 Nov 2020.