NCT04485819

Brief Summary

A Prospective cohort study including couples with poor responder females who undergoing ICSI

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration 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 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

2.9 years

First QC Date

July 22, 2020

Last Update Submit

July 22, 2020

Conditions

Poor Response to Ovulation InductionInfertility, Female

Keywords

Poor respondersEmbryo transferCancellation rateImplantation rateLive birth rate

Outcome Measures

Primary Outcomes (2)

  • Live birth rate

    percentage of cycles started with the intent of egg retrieval that led to a live birth.

    delivery of healthy neonate after 37 weeks of pregnancy

  • Implantation rate

    Percentage of the implanted embryos number for each group / number of transferred embryos.

    6 weeks of pregnancy

Secondary Outcomes (7)

  • Clinical pregnancy rate

    after 6 weeks of embryonic transfer

  • Cancellation rate

    5:6 days of ICSI

  • Fertilization rate

    16:19 hours after intracytoplasmic injection(ICSI)

  • Cleavage rate

    72 hours after ICSI

  • High quality day 3 embryos

    72 hours after ICSI

  • +2 more secondary outcomes

Study Arms (2)

Cleavage stage transfer

Poor responders who transfer their embryos in cleavage stage on day 3

Other: Cleavage stage transfer

Blast stage transfer

Poor responders who transfer their embryos on blast stage on day 5/6

Other: Blast stage transfer

Interventions

Cleavage stage transferOTHER

transferring embryos through ICSI procedures for poor responders on cleavage stage of embryonic development.

Cleavage stage transfer
Blast stage transferOTHER

transferring embryos through ICSI procedures for poor responders on blast stage of embryonic development.

Blast stage transfer

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspoor responders females with AMH≤ 1.2ng and have ≤ 5 mature oocytes
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Poor responders undergoing ICSI procedures at Ganin fertility center in Egypt

You may qualify if:

  • poor responders females with AMH≤ 1.2ng and have ≤ 5 mature oocytes
  • couples whose planning to do fresh transfer
  • male partners have normal semen parameters according to WHO 2010.

You may not qualify if:

  • sperm or oocyte donation
  • gestational carriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ganin fertility center

Cairo, 11728, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

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

Study Officials

  • Manar Hozyen, MSc.

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Amira Hassan, BSc.

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Hanaa Elkhader, BSc.

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Hosam Zaki

    Ganin Fertility Center

    STUDY CHAIR

Central Study Contacts

Manar M Hozyen, MSc.

CONTACT

+2001229483320manarnrc@gmail.com

Amira Hassan, BSc.

CONTACT

manarnrc@gmail.com

Study Design

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

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 24, 2020

Study Start

January 1, 2019

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

July 24, 2020

Record last verified: 2020-07

Locations

EG(1)