InfertilityPCSNCT03913208
Priority to Cryopreservation Strategy (PCS) in IVF-ICSI Cycles
A study testing Priority to freeze and Fresh embryo transfer in people with Infertility and IVF, run by Tanta University at 1 site in Egypt.
Trial summary
This multicentre randomized controlled trial will be done to evaluate a new strategy in IVF-ICSI practice that gives that priority to freeze for the embryos and goes to fresh embryo transfer only if at least one set of same quality embryos is available for cryopreservation. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility, IVF, ICSI
- What is being tested?
- Priority to freeze and Fresh embryo transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 31 Dec 2024
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Candidates for IVF/ICSI
- Presence of good number of embryos > 5
Who cannot join
- Low quality embryos
- Low ovarian reserve
- Low number of embryos
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Priority to Cryopreservation Strategy (PCS) in IVF-ICSI Cycles is it Going to Make the Difference?
This multicentre randomized controlled trial will be done to evaluate a new strategy in IVF-ICSI practice that gives that priority to freeze for the embryos and goes to fresh embryo transfer only if at least one set of same quality embryos is available for cryopreservation.
Read the detailed description
This study will be a non-blind, prospective, double-armed, randomized clinical trial. The study will be conducted at five centers, the Educational Hospital Fertility Unit of Tanta University, the fertility center of Cairo University, the fertility center of Assiut University, the Egyptian Consultants Fertility Center in Tanta, and MRC fertility center in Cairo from May 1st 2019 till the end of the objected number. The study will be conducted in accordance with the Declaration of Helsinki, and all participants should sign a written informed consent before inclusion in the study.
- Conditions
- Infertility, IVF, ICSI, Cryopreservation
- Being tested
- Priority to freeze, Fresh embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Priority to freezeProcedure or surgery
Priority for cryopreservation and later on embryo transfer in artificial cycle with endometrium preparation by the exogenous administration of estrogen-progesterone.
Fresh embryo transferProcedure or surgery
usual strategy of giving the priority for fresh embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Will be subjected to priority to freeze Receives: Procedure: Priority to freeze |
| Control group | Active comparator | Will receive fresh embryo transfere Receives: Procedure: Fresh embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative pregnancy rates
The number of pregnant women in both groups after 3 cycles
Measured: 3 months
Secondary outcomes (1)
Failure of pregnancy
Failed ICSI
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start1 May 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
- Investigators
- Ahmed Elhalwagy, MD, Study director, Tanta UniversitYaser Mesbah, MD, Study chair, Mansiura UniversityAhmed Abbas, MD, Study chair, Assiut UniversityAhmed Elsawaf, MD, Study chair, Cairo UniversityShereef Elshowaikh, MD, Study chair, Tanta UniversityAbdelghaffar Dawood, MD, Study chair, Tanta UniversityAhmed Elkhyat, MD, Study chair, Tanta UniversityShereen Elbohoty, MD, Study chair, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913208
- Sponsor's protocol ID
- PCS
- Acronym
- PCS
- Status last verified
- Jul 2023
- First submitted
- 10 Apr 2019
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will decide the type of data to share
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Priority to Cryopreservation Strategy (PCS) in IVF-ICSI Cycles is it Going to Make the Difference?
- ClinicalTrials.gov ID
- NCT03913208
- Acronym / sponsor ID
- PCS / PCS
- Conditions
- Infertility, IVF, ICSI, Cryopreservation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Apr 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 multicentre randomized controlled trial will be done to evaluate a new strategy in IVF-ICSI practice that gives that priority to freeze for the embryos and goes to fresh embryo transfer only if at least one set of same quality embryos is available for cryopreservation.
Detailed description
This study will be a non-blind, prospective, double-armed, randomized clinical trial. The study will be conducted at five centers, the Educational Hospital Fertility Unit of Tanta University, the fertility center of Cairo University, the fertility center of Assiut University, the Egyptian Consultants Fertility Center in Tanta, and MRC fertility center in Cairo from May 1st 2019 till the end of the objected number. The study will be conducted in accordance with the Declaration of Helsinki, and all participants should sign a written informed consent before inclusion in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Priority to freezeWill be subjected to priority to freeze |
| Control group | Active comparator | Procedure: Fresh embryo transferWill receive fresh embryo transfere |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Candidates for IVF/ICSI
- Presence of good number of embryos > 5
Key exclusion criteria (3 listed)
- Low quality embryos
- Low ovarian reserve
- Low number of embryos
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 |
|---|---|---|
| Priority to freezePriority for cryopreservation and later on embryo transfer in artificial cycle with endometrium preparation by the exogenous administration of estrogen-progesterone. | Procedure or surgery | Study group |
| Fresh embryo transferusual strategy of giving the priority for fresh embryo transfer | Procedure or surgery | Control group |
Primary outcome
Cumulative pregnancy rates
Time frame: 3 months
The number of pregnant women in both groups after 3 cycles
1 secondary outcome
Failure of pregnancy
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: Yes. We will decide the type of data to share
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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.
Ahmed Elhalwagy, MD study director
Tanta Universit
Yaser Mesbah, MD study chair
Mansiura University
Ahmed Abbas, MD study chair
Assiut 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 Priority to freeze and Fresh embryo transfer in people with Infertility and IVF, run by Tanta University at 1 site in Egypt.
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 3 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 18 Jul 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayman Dawood, MD (+201020972067, ayman.dawood@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative pregnancy rates (time frame: 3 months). 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 18 Jul 2023.