Pregnancy OutcomePhase 2NCT04434495
Outcome of Platelet Rich Plasma in ICSI Patients, a Randomized Controlled Trial
A Phase 2 study testing PRP in people with Pregnancy Outcome, run by Dr. Osman Hospital.
Trial summary
2 groups randomized to PRP injectioninto uterine cavity at mock embryo transfer, and a control group with only mock embryo transfer. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 788 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2020to 15 Apr 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
- Normoresponder patients (i.e. patients with 9 to 15 mature follicles on the day of HCG administration ) with expected good reproductive outcomes of IVF-ET and candidates for fresh embryo transfer
Who cannot join
- Age less than 18 years and more than 35 years Body mass index more than 30kg/m2 Serum progesterone level less than 1.5 ng/ml on the trigger day Smoking Moreover, patients with previous IVF cycle, PCOS ( polycystic ovarian syndrome), pelvic inflammatory disease, endometriosis, uterine anomalies, Ashermann syndrome, chronic endometritis, chromosomal anomalies, increased peripheral NK cells, hereditary thrombophylia and antiphospholipid syndrome were excluded from the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcome of Platelet Rich Plasma Injection in ICSI Patients, a Randomized Controlled Trial
2 groups randomized to PRP injectioninto uterine cavity at mock embryo transfer, and a control group with only mock embryo transfer.
Read the detailed description
Participants are allocated in two groups ( randomized). Study is conducted in Dar El Teb infertility and IVF centre, Egypt. Normoresponder patients (9-15 mature follicles on day of HCG administration) and candidates for fresh embryo transfer are recruited to the study. 788 patients will be randomized on the day of ovum pick up in a 1 to 1 ratio to platelet rich plasma (PRP) group and control group. Patients wee randomized using computer generated randomization list and sequentially numbered sealed envelopes containing allocation information written on a card. The embryologist and doctors responsible for follow up after ovum pick up aew blinded to received treatment. Ovarian stimunlation is achieved by highly purified urinary FSH (Fostimon, IBSA, Switzerland)started on the 2nd or 3rd day of menstruation. The initial dose ranged between 150-300IU/d depending on expected ovarian response and serum E2 level. GnRH antagonist (Cetrotide, Serono international, Geneva, Switzerland) 0.25mgSC/day will be give when the leading follicle is 14mm and continued till day of HCG. 10,000 IU HCG will be given when 3 or more follicles are 18mm on mean diameter. Oocyte retrieval will be performed 34-36 hours after HCG administration. In PRP group, 1 ml autologous PRP prepared from blood of participants and injected under ultrasound guidance inside the uterus while performing the mock embryo transfer. In control group, mock embryo transfer was performed without injecting anything inside the uterus. All participants will receive progesterone vaginal pessaries (Prontogest, Marcyrl, Egypt) 400 mg twicw daily, starting on day of oocyte retrieval till 12weeks gestation or negative pregnancy test. No more than 3 embryos will be transferred2-5 days after oocyte retrival. B HCG levels will be measured in blood 14 days after HCGadministration. Transvaginal ultrasound will be 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
PRP injection into uterine cavity
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | mock embryo transfer and PRP injection Receives: Biological: PRP |
| control group | No intervention | only mock embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
The presence of 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 transferred
Measured: Four weeks post intervention
Ongoing pregnancy rate
Number of continued pregnancies beyond 20 weeks gestation
Measured: Five months post intervention
Abortion rate
Number of pregnancies terminated before 20 weeks gestation
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 Nov 2020 (estimated)
- Study completion15 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 788 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Osman Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Hisham Gouda, Cairo University
- Investigators
- Hisham Gouda, MD, Principal investigator, Assistant prof Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434495
- Sponsor's protocol ID
- DrOsmanH
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Outcome of Platelet Rich Plasma Injection in ICSI Patients, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04434495
- Acronym / sponsor ID
- DrOsmanH
- Conditions
- Pregnancy Outcome
- Keywords
- PRP, IVF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 788 participants (estimated)
- Lead sponsor
- Dr. Osman HospitalUniversity, hospital or other
- Study start
- 15 Jun 2020 (estimated)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Apr 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.
2 groups randomized to PRP injectioninto uterine cavity at mock embryo transfer, and a control group with only mock embryo transfer.
Detailed description
Participants are allocated in two groups ( randomized). Study is conducted in Dar El Teb infertility and IVF centre, Egypt. Normoresponder patients (9-15 mature follicles on day of HCG administration) and candidates for fresh embryo transfer are recruited to the study. 788 patients will be randomized on the day of ovum pick up in a 1 to 1 ratio to platelet rich plasma (PRP) group and control group. Patients wee randomized using computer generated randomization list and sequentially numbered sealed envelopes containing allocation information written on a card. The embryologist and doctors responsible for follow up after ovum pick up aew blinded to received treatment. Ovarian stimunlation is achieved by highly purified urinary FSH (Fostimon, IBSA, Switzerland)started on the 2nd or 3rd day of menstruation. The initial dose ranged between 150-300IU/d depending on expected ovarian response and serum E2 level. GnRH antagonist (Cetrotide, Serono international, Geneva, Switzerland) 0.25mgSC/day will be give when the leading follicle is 14mm and continued till day of HCG. 10,000 IU HCG will be given when 3 or more follicles are 18mm on mean diameter. Oocyte retrieval will be performed 34-36 hours after HCG administration. In PRP group, 1 ml autologous PRP prepared from blood of participants and injected under ultrasound guidance inside the uterus while performing the mock embryo transfer. In control group, mock embryo transfer was performed without injecting anything inside the uterus. All participants will receive progesterone vaginal pessaries (Prontogest, Marcyrl, Egypt) 400 mg twicw daily, starting on day of oocyte retrieval till 12weeks gestation or negative pregnancy test. No more than 3 embryos will be transferred2-5 days after oocyte retrival. B HCG levels will be measured in blood 14 days after HCGadministration. Transvaginal ultrasound will be 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: PRPmock embryo transfer and PRP injection |
| control group | No intervention | –only mock embryo transfer |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normoresponder patients (i.e. patients with 9 to 15 mature follicles on the day of HCG administration ) with expected good reproductive outcomes of IVF-ET and candidates for fresh embryo transfer
Key exclusion criteria (1 listed)
- Age less than 18 years and more than 35 years Body mass index more than 30kg/m2 Serum progesterone level less than 1.5 ng/ml on the trigger day Smoking Moreover, patients with previous IVF cycle, PCOS ( polycystic ovarian syndrome), pelvic inflammatory disease, endometriosis, uterine anomalies, Ashermann syndrome, chronic endometritis, chromosomal anomalies, increased peripheral NK cells, hereditary thrombophylia and antiphospholipid syndrome were excluded from the study
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 |
|---|---|---|
| PRPPRP injection into uterine cavity | Biological | PRP group |
Primary outcome
Clinical pregnancy rate
Time frame: Four weeks post intervention
The presence of 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.
- 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 1 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, Sheemer75@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?
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.