NCT05778331

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

February 28, 2023

Last Update Submit

March 19, 2023

Conditions

Infertility, FemaleIVF

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Implantation rate after embryo transfer

    Untill all patient has been recruited - about 6 months

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

    Untill all patient has been recruited - about 6 months

  • Fertilization rate.

    Untill all patient has been recruited - about 6 months

Study Arms (2)

Group A : POSEIDON group 3

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

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

Procedure: Antagonist protocol for induction of ovulation

Interventions

Antagonist protocol for induction of ovulationPROCEDURE

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 A : POSEIDON group 3Group B: POSEIDON group 4

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Ovulation Induction

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 21, 2023

Study Start

January 10, 2023

Primary Completion

July 1, 2023

Study Completion

September 1, 2023

Last Updated

March 21, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)