Pregnancy OutcomePhase 2PRPNCT04434547
A RCT on the Effect of Platelets Rich Plasma in ICSI Patients With Recurrent Implantation Failure
A Phase 2 study testing PRP in people with Pregnancy Outcome, run by Dr. Osman Hospital.
Trial summary
This randomized controlled trial will be performed on 86 patients with recurrent implantation failure at Dar El Teb infertility and IVF center . Patients were randomized on a 1 to 1 ratio to platelets rich plasma ( PRP) group and control group. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pregnancy Outcome
- What is being tested?
- PRP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2020to 15 Mar 2021
- Phase
- Phase 2
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients with history of three or more unsuccessful IVF-ET cycles with at least two good quality embryos transferred and candidates for fresh embryo transfer
Who cannot join
- Age less than 18 years or more than 35years and body mass index more than 30 kg/m2.
- Patients with PCOS, endometriosis, uterine anomalies , Ashermann syndrome, chronic endometritis, chromosomal abnormalities, increased peripheral NK cells, hereditary thrombophylia and anti phospholipid syndrome
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial on the Effect of Adding Platelets Rich Plasma Intrauterine on the Day of Ovum Pickup in ICSI Patients With Recurrent Implantation Failure
This randomized controlled trial will be performed on 86 patients with recurrent implantation failure at Dar El Teb infertility and IVF center . Patients were randomized on a 1 to 1 ratio to platelets rich plasma ( PRP) group and control group.
Ovarian stimulation was achieved using highly purified urinary FSH starting on the 2 nd or 3rd day of the cycle . GnRH agonist ( cetrotide) 0.25 mg SC/ day was administered when the leading follicle reached 14mm in mean diameter and a dose of 10000 IU of HCG was administered when 3 or more follicles were 18mm or more in diameter..
Read more
Oocyte retrieval was done under ultrasound guidance and in the PRP group 1 ml of platelets rich plasma was infused inside the uterus while performing the mock embryo transfer while in the control group the mock embryo transfer was performed without injecting anything inside the uterus .
All patients received progesterone supplementation and embryo transfer was performed 3 to 5 days after oocyte retrieval.
BHCG level was done 14 days after Embryo transfer and transvaginal ultrasound was done to confirm pregnancy 4 weeks later.
Read the detailed description
This two arm, allocation concealed ,assessor blinded randomized controlled trial is to be conducted at Dar ElTeb Infertility and IVF center ,Giza,Egypt between the period between June 2020 and March 2021.
Eighty six patients with recurrent implantation failure were randomized in a 1 to 1 ratio to platelets-rich plasma (PRP) group and the control group . Patients were randomized using computer generated randomization list and sequentially numbered sealed envelopes containing allocation written on a card. The randomization list and the sealed envelopes were prepared by a colleague who is not directly involved in the study . The embryologists and the doctors responsible for follow up of the patients after ovum pickup were blinded to received treatment.
Ovarian stimulation was achieved using highly purified urinary FSH ( HPuFSH) (Fostimon,IBSA, Switzerland) started on the 2nd or 3rd day of menstruation . The initial dose of HPuFSH ranged between 150 and 300 IU/day depending on expected ovarian response. The dose of HPuFSH was modified from stimulation day 5 in steps of 75 units every 2nd or 3rd day depending on serum E2 and follicular development assessed by transvaginal ultrasound.
GnRH agonist ( cetrolix acetate) (cetrotide) 0.25mg SC/day was administered when the leading follicle reached 14 mm in mean diameter and was continued until and including the day of HCG administration .
A dose of 10000 IU of HCG was administered when 3 or more follicles were 18mm or more in mean diameter .
Oocyte retrieval under transvaginal ultrasound guidance was performed 34 hours after HCG administration .
In PRP group autologous platelets rich plasma was prepared from the blood using the two step centrifuge process. Under ultrasound guidance and complete aseptic procedures ,the endometrial thickness was measured then 1 ml of PRP was infused inside the uterus while performing the mock embryo transfer . In the control group mock embryo transfer was performed without injecting anything inside the uterus .
All the patients received progesterone vaginal pessaries ( prontogest, Marcyryl, Egypt) 400mg twice daily , starting on the day of oocyte retrieval and continuing until 12 weeks gestation or negative pregnancy test.
No more than 3 embryos were transferred under ultrasound guidance 3 to 5 days after oocyte retrieval . B HCG level was detected in blood 14 days after Embryo transfer to confirm pregnancy and transvaginal ultrasound was performed 4 weeks after embryo transfer to confirm clinical pregnancy.
- Conditions
- Pregnancy Outcome
- Being tested
- PRP
- Keywords
- PRP , IVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPBiological
Also called Platelets rich plasma
During the mock embryo transfer on oocyte retrieval day, 1ml of PRP was infused inside the uterus
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | In the PRP group autologous platelets rich plasma was prepared from the blood using the two step centifuge process .Under ultrasound guidance and complete aseptic procedure , 1 ml of PRP was infused inside the uterus while performing the mock embryo transfer Receives: Biological: PRP |
| Control group | No intervention | In the control group mock embryo transfer was performed without injecting anything inside the uterus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
The presence of a gestational sac by transvaginal ultrasound
Measured: Four weeks post intervention
Secondary outcomes (3)
Implantation rate
The number of gestational sacs detected by ultrasound divided by the number of embryos
Measured: Four weeks post intervention
Ongoing pregnancy rate
Pregnancies continuing beyond the 20th week
Measured: Five months post intervention
Abortion rate
Pregnancies terminated before 20 weeks
Measured: Five months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start15 Jun 2020 (estimated)
- Primary completion15 Oct 2020 (estimated)
- Study completion15 Mar 2021 (estimated)
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 Pregnancy OutcomeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Osman Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Hisham Gouda, Dr. Osman Hospital
- Investigators
- Hisham Gouda, MD, Principal investigator, Assistant prof Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434547
- Sponsor's protocol ID
- DrHGouda
- Acronym
- PRP
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nazari L, Salehpour S, Hosseini MS, Hashemi Moghanjoughi P. The effects of autologous platelet-rich plasma in repeated implantation failure: a randomized controlled trial. Hum Fertil (Camb). 2020 Sep;23(3):209-213. doi: 10.1080/14647273.2019.1569268. Epub 2019 Feb 4.
PubMed 30714427
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effect of Adding Platelets Rich Plasma Intrauterine on the Day of Ovum Pickup in ICSI Patients With Recurrent Implantation Failure
- ClinicalTrials.gov ID
- NCT04434547
- Acronym / sponsor ID
- PRP / DrHGouda
- Conditions
- Pregnancy Outcome
- Keywords
- PRP , IVF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Dr. Osman HospitalUniversity, hospital or other
- Study start
- 15 Jun 2020 (estimated)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 15 Mar 2021 (estimated)
- First posted
- 17 Jun 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.
This randomized controlled trial will be performed on 86 patients with recurrent implantation failure at Dar El Teb infertility and IVF center . Patients were randomized on a 1 to 1 ratio to platelets rich plasma ( PRP) group and control group.
Ovarian stimulation was achieved using highly purified urinary FSH starting on the 2 nd or 3rd day of the cycle . GnRH agonist ( cetrotide) 0.25 mg SC/ day was administered when the leading follicle reached 14mm in mean diameter and a dose of 10000 IU of HCG was administered when 3 or more follicles were 18mm or more in diameter..
Oocyte retrieval was done under ultrasound guidance and in the PRP group 1 ml of platelets rich plasma was infused inside the uterus while performing the mock embryo transfer while in the control group the mock embryo transfer was performed without injecting anything inside the uterus .
All patients received progesterone supplementation and embryo transfer was performed 3 to 5 days after oocyte retrieval.
BHCG level was done 14 days after Embryo transfer and transvaginal ultrasound was done to confirm pregnancy 4 weeks later.
Detailed description
This two arm, allocation concealed ,assessor blinded randomized controlled trial is to be conducted at Dar ElTeb Infertility and IVF center ,Giza,Egypt between the period between June 2020 and March 2021.
Eighty six patients with recurrent implantation failure were randomized in a 1 to 1 ratio to platelets-rich plasma (PRP) group and the control group . Patients were randomized using computer generated randomization list and sequentially numbered sealed envelopes containing allocation written on a card. The randomization list and the sealed envelopes were prepared by a colleague who is not directly involved in the study . The embryologists and the doctors responsible for follow up of the patients after ovum pickup were blinded to received treatment.
Ovarian stimulation was achieved using highly purified urinary FSH ( HPuFSH) (Fostimon,IBSA, Switzerland) started on the 2nd or 3rd day of menstruation . The initial dose of HPuFSH ranged between 150 and 300 IU/day depending on expected ovarian response. The dose of HPuFSH was modified from stimulation day 5 in steps of 75 units every 2nd or 3rd day depending on serum E2 and follicular development assessed by transvaginal ultrasound.
GnRH agonist ( cetrolix acetate) (cetrotide) 0.25mg SC/day was administered when the leading follicle reached 14 mm in mean diameter and was continued until and including the day of HCG administration .
A dose of 10000 IU of HCG was administered when 3 or more follicles were 18mm or more in mean diameter .
Oocyte retrieval under transvaginal ultrasound guidance was performed 34 hours after HCG administration .
In PRP group autologous platelets rich plasma was prepared from the blood using the two step centrifuge process. Under ultrasound guidance and complete aseptic procedures ,the endometrial thickness was measured then 1 ml of PRP was infused inside the uterus while performing the mock embryo transfer . In the control group mock embryo transfer was performed without injecting anything inside the uterus .
All the patients received progesterone vaginal pessaries ( prontogest, Marcyryl, Egypt) 400mg twice daily , starting on the day of oocyte retrieval and continuing until 12 weeks gestation or negative pregnancy test.
No more than 3 embryos were transferred under ultrasound guidance 3 to 5 days after oocyte retrieval . B HCG level was detected in blood 14 days after Embryo transfer to confirm pregnancy and transvaginal ultrasound was performed 4 weeks after embryo transfer to confirm clinical pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Biological: PRPIn the PRP group autologous platelets rich plasma was prepared from the blood using the two step centifuge process .Under ultrasound guidance and complete aseptic procedure , 1 ml of PRP was infused inside the uterus while performing the mock embryo transfer |
| Control group | No intervention | –In the control group mock embryo transfer was performed without injecting anything inside the uterus. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with history of three or more unsuccessful IVF-ET cycles with at least two good quality embryos transferred and candidates for fresh embryo transfer
Key exclusion criteria (2 listed)
- Age less than 18 years or more than 35years and body mass index more than 30 kg/m2.
- Patients with PCOS, endometriosis, uterine anomalies , Ashermann syndrome, chronic endometritis, chromosomal abnormalities, increased peripheral NK cells, hereditary thrombophylia and anti phospholipid syndrome
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 |
|---|---|---|
| PRPAlso: Platelets rich plasmaDuring the mock embryo transfer on oocyte retrieval day, 1ml of PRP was infused inside the uterus | Biological | PRP group |
Primary outcome
Clinical pregnancy rate
Time frame: Four weeks post intervention
The presence of a gestational sac by transvaginal ultrasound
3 secondary outcomes
Implantation rate
Time frame: Four weeks post intervention
Ongoing pregnancy rate
Time frame: Five months post intervention
Abortion rate
Time frame: Five months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Background: PubMed 30714427Nazari L, Salehpour S, Hosseini MS, Hashemi Moghanjoughi P. The effects of autologous platelet-rich plasma in repeated implantation failure: a randomized controlled trial. Hum Fertil (Camb). 2020 Sep;23(3):209-213. doi: 10.1080/14647273.2019.1569268. Epub 2019 Feb 4.
- 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.
Hisham Gouda, MD principal investigator
Assistant prof Cairo university
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRP in people with Pregnancy Outcome, run by Dr. Osman Hospital.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hisham Gouda, MD (00201001885885, Sheemeer75@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: Four weeks post intervention). 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 NCT04434547, 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 17 Jun 2020.