Current partner codePEPTIDESDE
NCT05778331·Not applicable·OBSERVATIONAL

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

Status

Unknown

Phase

Not applicable

Enrollment

340

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Mar 21, 2023

  2. Study start

    Jan 10, 2023

  3. Primary completion

    Jul 2023

  4. Study completion

    Sep 2023

  5. Results posted

    Not reported

  6. Registry updated

    Mar 21, 2023

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

Implantation rate after embryo transfer

Time frame · Untill all patient has been recruited - about 6 months

number of gestational sac/ total number of transferred embryo

Number of high quality grade A embryos on day 3 and blastocyst.

Time frame · Untill all patient has been recruited - about 6 months

number of grade A embryos

Fertilization rate.

Time frame · Untill all patient has been recruited - about 6 months

number of fertilized ovum / number of retrieved oocyte

Eligibility

Who can take part.

Minimum age
25 Years
Maximum age
50 Years
Sex
FEMALE
Healthy volunteers
Yes

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 locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Ain Shams University

Cairo, Egypt

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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