Recurrent Implantation FailureNCT03996837
Platelet Rich Plasma and Recurrent Implantation Failure
A study testing Intra uterine infusion of platelet rich plasma in people with Recurrent Implantation Failure, run by Royan Institute at 1 site in Iran.
Trial summary
This study is a randomized controlled clinical trial to compare the pregnancy outcomes of infertile women with recurrent implantation failure. The study population consisted of infertile women with a history of recurrent implantation failure who had failed to achieve a clinical pregnancy which at least four good… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Implantation Failure
- What is being tested?
- Intra uterine infusion of platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- 16 Aug 2017to 21 May 2022
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertile women with a history of recurrent implantation failure who had failed to achieve a clinical pregnancy which at least four good quality embryos transfers
- 20<Age<40
- 19<BMI<29
- Non endocrine, hematologic and autoimmune disorders
- Non chromosomal and genetic abnormalities
- Non uterine anomalies, surgical history, endometriosis, adenomyosis, hydro salpinx, uterine fibroids, Polycystic ovary syndrome
- Having at least three good quality embryos
Who cannot join
- Cervicitis
- Recent fever condition
- Use of corticosteroids (in up to 2 weeks before the procedure) or non-steroid anti-inflammatories (in up to 48 hours before procedure)
- Anemia, thrombocytopenia, platelet dysfunction syndrome, hypofibrinogenemia
- Septicemia, active infections with Pseudomonas, Klebsiella or Enterococcus
- History of cancer
- Patient's tendency for withdrawal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Application Platelet Rich Plasma in the Treatment of Patients With Recurrent Implantation Failure in IVF-ICSI & Freeze Embryo Transfer Cycles in Royan Institute; a Randomized Controlled Trial
This study is a randomized controlled clinical trial to compare the pregnancy outcomes of infertile women with recurrent implantation failure. The study population consisted of infertile women with a history of recurrent implantation failure who had failed to achieve a clinical pregnancy which at least four good quality embryos transfers and are now candidate for IVF-ICSI or freeze embryo transfer cycles with and without intra uterine infusion of platelet rich plasma in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.
Read the detailed description
Platelet Rich Plasma (PRP) is a blood product with a high platelet and a normal plasma fibrinogen level. Given the effective factors of RPR in repairing damaged tissues, its application in the field of regenerative medicine has widely been interested over the last three decades. According to the literature, PRP is an effective and safe treatment in the fields of orthopaedics, dermatology, ophthalmology, and repair of neurological, vascular, and connective tissue damage, but its application in the field of infertility is limited to a few pilot studies in which the effects of PRP on endometrium and recurrent implantation failure (RIF) were investigated. Given the importance of endometrial compliance and according to molecular studies, which indicate that endometrial growth factors in women with a history of RIF are lower than normal fertile women, PRP, along with other existing strategies, can be used to improve endometrial compliance in patients with a history of RIF. The present randomized, controlled clinical trial is proposed to determine the efficacy of PRP in the treatment of patients with RIF in the cycles of IVF-ICSI and frozen embryo transfer at Royan Institute.
- Conditions
- Recurrent Implantation Failure
- Being tested
- Intra uterine infusion of platelet rich plasma
- Keywords
- Platelet rich plasma, Recurrent implantation failure, Infertility, Assisted reproduction technology
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra uterine infusion of platelet rich plasmaOther
Platelet Rich Plasma (PRP) is a blood product with a high platelet and a normal plasma fibrinogen level. Given the effective factors of RPR in repairing damaged tissues, its application in the field of regenerative medicine has widely been interested over the last three decades. According to the literature, PRP is an effective and safe treatment in the fields of orthopaedics, dermatology, ophthalmology, and repair of neurological, vascular, and connective tissue damage, but its application in the field of infertility is limited to a few pilot studies in which the effects of PRP on endometrium and recurrent implantation failure (RIF) were investigated.
| Study group | Role | What they receive |
|---|---|---|
| Fresh embryo transfer with intra uterine infusion of PRP | Experimental | In IVF-ICSI cycles, ovulation will be stimulated through the standard protocol using a gonadotropin-releasing hormone agonist for all patients. 48 hours after the oocyte retrieval and ensuring that at least 3 good quality embryos are formed, patients will be randomized into two groups of with and without PRP intrauterine injection. For all patients, 2 embryos in the blastocyst stage with excellent or good quality will be transferred. One milliliter PRP will be injected into the patients' uterine cavity using an embryo transfer catheter (Labotect Gmbh, Labor-Technik-Gottingen Kampweg 12, 37124 Rosdorf, Germany) 48 hours before embryo transfer. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients in the control group 48 hours before the embryo transfer without any injections. Receives: Other: Intra uterine infusion of platelet rich plasma |
| Fresh embryo transfer without intra uterine infusion of PRP | No intervention | In IVF-ICSI cycles, ovulation will be stimulated through the standard protocol using a gonadotropin-releasing hormone agonist for all patients. 48 hours after the oocyte retrieval and ensuring that at least 3 good quality embryos are formed, patients will be randomized into two groups of with and without PRP intrauterine injection. For all patients, 2 embryos in the blastocyst stage with excellent or good quality will be transferred. One milliliter PRP will be injected into the patients' uterine cavity using an embryo transfer catheter (Labotect Gmbh, Labor-Technik-Gottingen Kampweg 12, 37124 Rosdorf, Germany) 48 hours before embryo transfer. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients in the control group 48 hours before the embryo transfer without any injections. |
| Freeze embryo transfer with intra uterine infusion of PRP | Experimental | In frozen embryos transfer cycles, the endometrium of all patients will be prepared through the standard protocol using a gonadotropin-releasing hormone agonist. Following this process, 2 embryos in the blastocyst stage with good or excellent quality will be transferred. It is worth mentioning that in 48 hours prior to the embryo transfer; 1 mL of PRP will be injected into the uterine cavity using an embryo transfer catheter. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients in the control group 48 hours before the embryo transfer without any injections. Receives: Other: Intra uterine infusion of platelet rich plasma |
| Freeze embryo transfer without intra uterine infusion of PRP | No intervention | In frozen embryos transfer cycles, the endometrium of all patients will be prepared through the standard protocol using a gonadotropin-releasing hormone agonist. Following this process, 2 embryos in the blastocyst stage with good or excellent quality will be transferred. It is worth mentioning that in 48 hours prior to the embryo transfer; 1 mL of PRP will be injected into the uterine cavity using an embryo transfer catheter. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients in the control group 48 hours before the embryo transfer without any injections. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
The number of gestational sacs observed, divided by the number of embryos transferred
Measured: 4-6 weeks after embryo transfer
Secondary outcomes (1)
Ongoing pregnancy rate
Continued pregnancy at > gestational week 12 or more per initiated cycle
Measured: 12 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start16 Aug 2017
- Primary completion17 Nov 2021
- Study completion21 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Implantation FailureStudies 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996837
- Sponsor's protocol ID
- PRP-RIF
- Status last verified
- Jan 2024
- First submitted
- 26 May 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yahyaei A, Madani T, Vesali S, Mashayekhi M. Intrauterine infusion of autologous platelet rich plasma can be an efficient treatment for patients with unexplained recurrent implantation failure. Sci Rep. 2024 Oct 29;14(1):26009. doi: 10.1038/s41598-024-77578-1.
PubMed 39472511
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Application Platelet Rich Plasma in the Treatment of Patients With Recurrent Implantation Failure in IVF-ICSI & Freeze Embryo Transfer Cycles in Royan Institute; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03996837
- Acronym / sponsor ID
- PRP-RIF
- Conditions
- Recurrent Implantation Failure
- Keywords
- Platelet rich plasma, Recurrent implantation failure, Infertility, Assisted reproduction technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 21 May 2022 (actual)
- First posted
- 25 Jun 2019 (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.
This study is a randomized controlled clinical trial to compare the pregnancy outcomes of infertile women with recurrent implantation failure. The study population consisted of infertile women with a history of recurrent implantation failure who had failed to achieve a clinical pregnancy which at least four good quality embryos transfers and are now candidate for IVF-ICSI or freeze embryo transfer cycles with and without intra uterine infusion of platelet rich plasma in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.
Detailed description
Platelet Rich Plasma (PRP) is a blood product with a high platelet and a normal plasma fibrinogen level. Given the effective factors of RPR in repairing damaged tissues, its application in the field of regenerative medicine has widely been interested over the last three decades. According to the literature, PRP is an effective and safe treatment in the fields of orthopaedics, dermatology, ophthalmology, and repair of neurological, vascular, and connective tissue damage, but its application in the field of infertility is limited to a few pilot studies in which the effects of PRP on endometrium and recurrent implantation failure (RIF) were investigated. Given the importance of endometrial compliance and according to molecular studies, which indicate that endometrial growth factors in women with a history of RIF are lower than normal fertile women, PRP, along with other existing strategies, can be used to improve endometrial compliance in patients with a history of RIF. The present randomized, controlled clinical trial is proposed to determine the efficacy of PRP in the treatment of patients with RIF in the cycles of IVF-ICSI and frozen embryo transfer at Royan Institute.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fresh embryo transfer with intra uterine infusion of PRP | Experimental | Other: Intra uterine infusion of platelet rich plasmaIn IVF-ICSI cycles, ovulation will be stimulated through the standard protocol using a gonadotropin-releasing hormone agonist for all patients. 48 hours after the oocyte retrieval and ensuring that at least 3 good quality embryos are formed, patients will be randomized into two groups of with and without PRP intrauterine injection. For all patients, 2 embryos in the blastocyst stage with excellent or good quality will be transferred. One milliliter PRP will be injected into the patients' uterine cavity using an embryo transfer catheter (Labotect Gmbh, Labor-Technik-Gottingen Kampweg 12, 37124 Rosdorf, Germany) 48 hours before embryo transfer. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients in the control group 48 hours before the embryo transfer without any injections. |
| Fresh embryo transfer without intra uterine infusion of PRP | No intervention | –In IVF-ICSI cycles, ovulation will be stimulated through the standard protocol using a gonadotropin-releasing hormone agonist for all patients. 48 hours after the oocyte retrieval and ensuring that at least 3 good quality embryos are formed, patients will be randomized into two groups of with and without PRP intrauterine injection. For all patients, 2 embryos in the blastocyst stage with excellent or good quality will be transferred. One milliliter PRP will be injected into the patients' uterine cavity using an embryo transfer catheter (Labotect Gmbh, Labor-Technik-Gottingen Kampweg 12, 37124 Rosdorf, Germany) 48 hours before embryo transfer. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients in the control group 48 hours before the embryo transfer without any injections. |
| Freeze embryo transfer with intra uterine infusion of PRP | Experimental | Other: Intra uterine infusion of platelet rich plasmaIn frozen embryos transfer cycles, the endometrium of all patients will be prepared through the standard protocol using a gonadotropin-releasing hormone agonist. Following this process, 2 embryos in the blastocyst stage with good or excellent quality will be transferred. It is worth mentioning that in 48 hours prior to the embryo transfer; 1 mL of PRP will be injected into the uterine cavity using an embryo transfer catheter. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients in the control group 48 hours before the embryo transfer without any injections. |
| Freeze embryo transfer without intra uterine infusion of PRP | No intervention | –In frozen embryos transfer cycles, the endometrium of all patients will be prepared through the standard protocol using a gonadotropin-releasing hormone agonist. Following this process, 2 embryos in the blastocyst stage with good or excellent quality will be transferred. It is worth mentioning that in 48 hours prior to the embryo transfer; 1 mL of PRP will be injected into the uterine cavity using an embryo transfer catheter. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients in the control group 48 hours before the embryo transfer without any injections. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Infertile women with a history of recurrent implantation failure who had failed to achieve a clinical pregnancy which at least four good quality embryos transfers
- 20<Age<40
- 19<BMI<29
- Non endocrine, hematologic and autoimmune disorders
- Non chromosomal and genetic abnormalities
Key exclusion criteria (7 listed)
- Cervicitis
- Recent fever condition
- Use of corticosteroids (in up to 2 weeks before the procedure) or non-steroid anti-inflammatories (in up to 48 hours before procedure)
- Anemia, thrombocytopenia, platelet dysfunction syndrome, hypofibrinogenemia
- Septicemia, active infections with Pseudomonas, Klebsiella or Enterococcus
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 |
|---|---|---|
| Intra uterine infusion of platelet rich plasmaPlatelet Rich Plasma (PRP) is a blood product with a high platelet and a normal plasma fibrinogen level. Given the effective factors of RPR in repairing damaged tissues, its application in the field of regenerative medicine has widely been interested over the last three decades. According to the literature, PRP is an effective and safe treatment in the fields of orthopaedics, dermatology, ophthalmology, and repair of neurological, vascular, and connective tissue damage, but its application in the field of infertility is limited to a few pilot studies in which the effects of PRP on endometrium and recurrent implantation failure (RIF) were investigated. | Other | Freeze embryo transfer with intra uterine infusion of PRP, Fresh embryo transfer with intra uterine infusion of PRP |
Primary outcome
Implantation rate
Time frame: 4-6 weeks after embryo transfer
The number of gestational sacs observed, divided by the number of embryos transferred
1 secondary outcome
Ongoing pregnancy rate
Time frame: 12 weeks after embryo transfer
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 3 Jan 2024.
- Derived from this study: PubMed 39472511Yahyaei A, Madani T, Vesali S, Mashayekhi M. Intrauterine infusion of autologous platelet rich plasma can be an efficient treatment for patients with unexplained recurrent implantation failure. Sci Rep. 2024 Oct 29;14(1):26009. doi: 10.1038/s41598-024-77578-1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra uterine infusion of platelet rich plasma in people with Recurrent Implantation Failure, run by Royan Institute at 1 site in Iran.
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 7 inclusion and 7 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 3 Jan 2024. 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 Iran. 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?
Implantation rate (time frame: 4-6 weeks after embryo transfer). 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 NCT03996837, which also lists 1 linked publication.
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 3 Jan 2024.