The Difference Between POSEIDON Group 3 and Group 4 as Regards IVF (POSEIDON)

prospective observational study over POSEIDON group 3 and POSEIDON group 4 with antagonist protocol for clinical pregnancy rate outcomes

Study Overview

• Status: Enrolling by invitation
• Conditions: Infertility, Female; IVF
• Intervention / Treatment: Procedure: Antagonist protocol for induction of ovulation

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:

1. Full history will be taken from targeted women (personal, previous obstetric, menstrual, surgical, previous ICSI).
2. Labs will be revised especially AMH , FSH , LH , E2 , prolactin , TSH.
3. AFC on day 2 or 3 of menses.
4. Full labs for chronic disease will be revised to exclude women with any chronic disease.
5. Ultrasound at least to exclude any anatomical uterine problem.
6. HSG .
7. Women who will be categorized as Poseidon group 3 (Group A) and Poseidon group 4 (Group B).
8. 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).
9. Assessment of embryo quality by embryologist on day 2 and day 3 to grade embryos and also checking of blastocyst formation on day 5.
10. 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 Type: Observational
• Enrollment (Anticipated): 340

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

(Poseidon group 4)

1. Age : ≥ 35 years old
2. AFC : < 5
3. AMH : < 1.2
4. Planning for IVF (Poseidon group 3)

1. Age : < 35 2. AFC: < 5 3. AMH : < 1.2 4. Planning for IVF

Exclusion Criteria:

1. Chronic medical disorders such as : hypertension, diabetes, etc as it may affect embryo quality and pregnancy rate .
2. Evidence of intrauterine pathology ( polyp , fibroid , adenomyosis) as it affect implantation rate.
3. Evidence uterine congenital anomaly(septum , bicornuate ) as it affects implantation rate.
4. Evidence of hydrosalpinx as it affects implantation rate.
5. Infertility due to azoospermia (male case of infertility) as it affects the rate of fertilization.
6. Patients already on other therapies(DHEA ,steroids, etc) as it affects pregnancy rate.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A : POSEIDON group 3; Age : < 35; AFC: < 5; AMH : < 1.2; Planning for IVF	Procedure: Antagonist protocol for induction of ovulation; 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
Group B: POSEIDON group 4; Age : ≥ 35 years old; AFC : < 5; AMH : < 1.2; Planning for IVF	Procedure: Antagonist protocol for induction of ovulation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rates.	number of clinical pregnancy/ number of embryo transfer cycle for each group	Untill all patient has been recruited - about 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation rate after embryo transfer	number of gestational sac/ total number of transferred embryo	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	Untill all patient has been recruited - about 6 months
Fertilization rate.	number of fertilized ovum / number of retrieved oocyte	Untill all patient has been recruited - about 6 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: March 19, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 19, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: MS 862/2022/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO