Infertility, FemalePOSEIDONNCT05778331
The Difference Between POSEIDON Group 3 and Group 4 as Regards IVF
An observational study of Infertility, Female and IVF, run by Ain Shams University at 1 site in Egypt.
Trial summary
prospective observational study over POSEIDON group 3 and POSEIDON group 4 with antagonist protocol for clinical pregnancy rate outcomes Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, IVF
- What is being tested?
- Antagonist protocol for induction of ovulation
- Type of treatment
- Surgery or procedure
- How many people
- 340 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2023to Sep 2023
- Phase
- Observational
- 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 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women who attend IVF clinic who will be categorized as poor ovarian responders specifically those categorized as Poseidon group 3 and Poseidon group 4 are planning to undergo ICSI/IVF.
Who may be able to join
- (Poseidon group 4)
- Age : ≥ 35 years old
- AFC : < 5
- AMH : < 1.2
- Planning for IVF (Poseidon group 3)
- 1. Age : < 35 2. AFC: < 5 3. AMH : < 1.2 4. Planning for IVF
Who cannot join
- Chronic medical disorders such as : hypertension, diabetes, etc as it may affect embryo quality and pregnancy rate .
- Evidence of intrauterine pathology ( polyp , fibroid , adenomyosis) as it affect implantation rate.
- Evidence uterine congenital anomaly(septum , bicornuate ) as it affects implantation rate.
- Evidence of hydrosalpinx as it affects implantation rate.
- Infertility due to azoospermia (male case of infertility) as it affects the rate of fertilization.
- Patients already on other therapies(DHEA ,steroids, etc) as it affects pregnancy rate.
Trial locations and contacts
1 site in 1 country.
About this study
prospective observational study over POSEIDON group 3 and POSEIDON group 4 with antagonist protocol for clinical pregnancy rate outcomes
Read the detailed description
Type of study: prospective observational study.
Study setting: Ain Shams University Maternity Hospital (IVF. unit) Specialized IVF centers in GIZAH
Study period: Until all needed patients have been recruited (about 6 months from start of the study).
Study population: women who attend IVF clinic who will be categorized as poor ovarian responders specifically those categorized as Poseidon group 3 and Poseidon group 4 are planning to undergo ICSI/IVF.
Sampling method: patients will be divided in 2 groups : Group A Poseidon group 3 \& Group B Poseidon group 4.
Sample size: The study will be conducted on 340 patients.
Sample justification: Using PASS 15 program for sample size calculation , setting power at 80% and α-error at 0.05 , and assuming clinical pregnancy rate of 21.3% for Poseidon group 3 and 10.3% for Poseidon group 4 , sample size of 170 women per group will be needed to detect difference between groups (RK abdullah , 2020).
Ethical consideration: The study will be done after the approval of the ethical committee of the department of obstetrics and gynecology, faculty of medicine, Ain Shams University. Informed consent will be taken from all participants before recruitment in the study, and after explaining the purpose and procedures of the study. The investigator will obtain the written, signed informed consent of each subject prior to performing Specific procedures on the subject. The investigator will retain the original signed informed consent form. The study will be based on the investigator self-funding.
Study procedure:
- Full history will be taken from targeted women (personal, previous obstetric, menstrual, surgical, previous ICSI).
- Labs will be revised especially AMH , FSH , LH , E2 , prolactin , TSH.
- AFC on day 2 or 3 of menses.
- Full labs for chronic disease will be revised to exclude women with any chronic disease.
- Ultrasound at least to exclude any anatomical uterine problem.
- HSG .
- Women who will be categorized as Poseidon group 3 (Group A) and Poseidon group 4 (Group B).
- They will be given after that antagonist protocol with dose of HMG/FSH 300-450 I.U. per day: (Gonapure 150 I.U -follicle stimulating hormone FSH preparation of recombinant DNA technology- MinaPharm pharmaceuticals-Egypt) will be given from 2nd day of menstruation per day as starting dose then on 7th day (Cetrotide 0.25 -Cetrorelix, an anti-gonadotropin releasing hormone- MERCK SORONO-Germany) will be given daily till triggering . US will be done to evaluate follicular size from 7th day if it will be 1.8 cm or more for at least 2 follicles then (Chorimon 5000 i.u-Choriogonadotropin Alfa-IBSA-Switzerland )of total dose 10000 I.U. will be given then ovum pick up with be done after 35 h of triggering ovulation (B.C. Tarlatzis, 2006).
- Assessment of embryo quality by embryologist on day 2 and day 3 to grade embryos and also checking of blastocyst formation on day 5.
- Embryo transfer (ET) will be done when it is on day 3 or day 5 based on the number and quality of available embryos.
- Conditions
- Infertility, Female, IVF
- Being tested
- Antagonist protocol for induction of ovulation
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antagonist protocol for induction of ovulationProcedure or surgery
Full labs will be revised to exclude women with any chronic disease. Ultrasound to exclude any anatomical uterine problem.HSG.Women who will be categorized as Poseidon group 3 and Poseidon group 4.They will be given after that antagonist protocol with dose of HMG/FSH 300-450 I.U. per day: (Gonapure 150 I.U -follicle stimulating hormone FSH preparation of recombinant DNA technology- MinaPharm pharmaceuticals-Egypt) will be given from 2nd day of menstruation per day as starting dose then on 7th day (Cetrotide 0.25 -Cetrorelix, an anti-gonadotropin releasing hormone- MERCK SORONO-Germany) will be given daily till triggering . US will be done to evaluate follicular size from 7th day if it will be 1.8 cm or more for at least 2 follicles then (Chorimon 5000 i.u-Choriogonadotropin Alfa-IBSA-Switzerland )of total dose 10000 I.U. will be given then ovum pick up with be done after 35 h of triggering ovulation .Assessment of embryo quality
| Study group | Role | What they receive |
|---|---|---|
| Group A : POSEIDON group 3 | 1. Age : < 35
2. AFC: < 5
3. AMH : < 1.2
4. Planning for IVF Receives: Procedure: Antagonist protocol for induction of ovulation | |
| Group B: POSEIDON group 4 | 1. Age : ≥ 35 years old
2. AFC : < 5
3. AMH : < 1.2
4. Planning for IVF Receives: Procedure: Antagonist protocol for induction of ovulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rates.
number of clinical pregnancy/ number of embryo transfer cycle for each group
Measured: Untill all patient has been recruited - about 6 months
Secondary outcomes (3)
Implantation rate after embryo transfer
number of gestational sac/ total number of transferred embryo
Measured: Untill all patient has been recruited - about 6 months
Number of high quality grade A embryos on day 3 and blastocyst.
number of grade A embryos
Measured: Untill all patient has been recruited - about 6 months
Fertilization rate.
number of fertilized ovum / number of retrieved oocyte
Measured: Untill all patient has been recruited - about 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start10 Jan 2023
- Primary completionJul 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778331
- Sponsor's protocol ID
- MS 862/2022/2023
- Acronym
- POSEIDON
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference Between POSEIDON Group 3 and Group 4 as Regards IVF
- ClinicalTrials.gov ID
- NCT05778331
- Acronym / sponsor ID
- POSEIDON / MS 862/2022/2023
- Conditions
- Infertility, Female, IVF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 21 Mar 2023 (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.
prospective observational study over POSEIDON group 3 and POSEIDON group 4 with antagonist protocol for clinical pregnancy rate outcomes
Detailed description
Type of study: prospective observational study.
Study setting: Ain Shams University Maternity Hospital (IVF. unit) Specialized IVF centers in GIZAH
Study period: Until all needed patients have been recruited (about 6 months from start of the study).
Study population: women who attend IVF clinic who will be categorized as poor ovarian responders specifically those categorized as Poseidon group 3 and Poseidon group 4 are planning to undergo ICSI/IVF.
Sampling method: patients will be divided in 2 groups : Group A Poseidon group 3 \& Group B Poseidon group 4.
Sample size: The study will be conducted on 340 patients.
Sample justification: Using PASS 15 program for sample size calculation , setting power at 80% and α-error at 0.05 , and assuming clinical pregnancy rate of 21.3% for Poseidon group 3 and 10.3% for Poseidon group 4 , sample size of 170 women per group will be needed to detect difference between groups (RK abdullah , 2020).
Ethical consideration: The study will be done after the approval of the ethical committee of the department of obstetrics and gynecology, faculty of medicine, Ain Shams University. Informed consent will be taken from all participants before recruitment in the study, and after explaining the purpose and procedures of the study. The investigator will obtain the written, signed informed consent of each subject prior to performing Specific procedures on the subject. The investigator will retain the original signed informed consent form. The study will be based on the investigator self-funding.
Study procedure:
- Full history will be taken from targeted women (personal, previous obstetric, menstrual, surgical, previous ICSI).
- Labs will be revised especially AMH , FSH , LH , E2 , prolactin , TSH.
- AFC on day 2 or 3 of menses.
- Full labs for chronic disease will be revised to exclude women with any chronic disease.
- Ultrasound at least to exclude any anatomical uterine problem.
- HSG .
- Women who will be categorized as Poseidon group 3 (Group A) and Poseidon group 4 (Group B).
- They will be given after that antagonist protocol with dose of HMG/FSH 300-450 I.U. per day: (Gonapure 150 I.U -follicle stimulating hormone FSH preparation of recombinant DNA technology- MinaPharm pharmaceuticals-Egypt) will be given from 2nd day of menstruation per day as starting dose then on 7th day (Cetrotide 0.25 -Cetrorelix, an anti-gonadotropin releasing hormone- MERCK SORONO-Germany) will be given daily till triggering . US will be done to evaluate follicular size from 7th day if it will be 1.8 cm or more for at least 2 follicles then (Chorimon 5000 i.u-Choriogonadotropin Alfa-IBSA-Switzerland )of total dose 10000 I.U. will be given then ovum pick up with be done after 35 h of triggering ovulation (B.C. Tarlatzis, 2006).
- Assessment of embryo quality by embryologist on day 2 and day 3 to grade embryos and also checking of blastocyst formation on day 5.
- Embryo transfer (ET) will be done when it is on day 3 or day 5 based on the number and quality of available embryos.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : POSEIDON group 3 | – | Procedure: Antagonist protocol for induction of ovulation1. Age : < 35 2. AFC: < 5 3. AMH : < 1.2 4. Planning for IVF |
| Group B: POSEIDON group 4 | – | Procedure: Antagonist protocol for induction of ovulation1. Age : ≥ 35 years old 2. AFC : < 5 3. AMH : < 1.2 4. Planning for IVF |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women who attend IVF clinic who will be categorized as poor ovarian responders specifically those categorized as Poseidon group 3 and Poseidon group 4 are planning to undergo ICSI/IVF.
Key inclusion criteria (6 listed)
- (Poseidon group 4)
- Age : ≥ 35 years old
- AFC : < 5
- AMH : < 1.2
- Planning for IVF (Poseidon group 3)
Key exclusion criteria (6 listed)
- Chronic medical disorders such as : hypertension, diabetes, etc as it may affect embryo quality and pregnancy rate .
- Evidence of intrauterine pathology ( polyp , fibroid , adenomyosis) as it affect implantation rate.
- Evidence uterine congenital anomaly(septum , bicornuate ) as it affects implantation rate.
- Evidence of hydrosalpinx as it affects implantation rate.
- Infertility due to azoospermia (male case of infertility) as it affects the rate of fertilization.
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 |
|---|---|---|
| Antagonist protocol for induction of ovulationFull labs will be revised to exclude women with any chronic disease. Ultrasound to exclude any anatomical uterine problem.HSG.Women who will be categorized as Poseidon group 3 and Poseidon group 4.They will be given after that antagonist protocol with dose of HMG/FSH 300-450 I.U. per day: (Gonapure 150 I.U -follicle stimulating hormone FSH preparation of recombinant DNA technology- MinaPharm pharmaceuticals-Egypt) will be given from 2nd day of menstruation per day as starting dose then on 7th day (Cetrotide 0.25 -Cetrorelix, an anti-gonadotropin releasing hormone- MERCK SORONO-Germany) will be given daily till triggering . US will be done to evaluate follicular size from 7th day if it will be 1.8 cm or more for at least 2 follicles then (Chorimon 5000 i.u-Choriogonadotropin Alfa-IBSA-Switzerland )of total dose 10000 I.U. will be given then ovum pick up with be done after 35 h of triggering ovulation .Assessment of embryo quality | Procedure or surgery | Group A : POSEIDON group 3, Group B: POSEIDON group 4 |
Primary outcome
Clinical pregnancy rates.
Time frame: Untill all patient has been recruited - about 6 months
number of clinical pregnancy/ number of embryo transfer cycle for each group
3 secondary outcomes
Implantation rate after embryo transfer
Time frame: Untill all patient has been recruited - about 6 months
Number of high quality grade A embryos on day 3 and blastocyst.
Time frame: Untill all patient has been recruited - about 6 months
Fertilization rate.
Time frame: Untill all patient has been recruited - about 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- 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?
An observational study of Infertility, Female and IVF, run by Ain Shams 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 6 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: status not confirmed, as of the sponsor's last update on 21 Mar 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?
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?
Clinical pregnancy rates. (time frame: Untill all patient has been recruited - about 6 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 21 Mar 2023; AzTrials last refreshed its copy on 28 Oct 2026.