Optimal Embryonic Stage for Transfer in Poor Responders

July 22, 2020 updated by: Ganin Fertility Center

Achieving Better Clinical Outcomes With Blastocyt Transfer in Poor Responders: a Prospective Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Purpose:

To determine the optimal embryonic stage for transfer in poor responders.

Method:

Patients were divided into day 3 transfer group and day 5 transfer group. All cases had the same stimulation protocol and planning to do fresh embryo transfer. Assessments will be at Day 1, Day 3 and Day 5/6 according to Gardner's criteria 1999. Embryological and clinical data were recorded and then analyzed using SPSS (version 23) statistical software.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11728
        • Recruiting
        • Ganin Fertility Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Poor responders undergoing ICSI procedures at Ganin fertility center in Egypt

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • sperm or oocyte donation
  • gestational carriers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cleavage stage transfer
Poor responders who transfer their embryos in cleavage stage on day 3
Other: Cleavage stage transfer
transferring embryos through ICSI procedures for poor responders on cleavage stage of embryonic development.
Blast stage transfer
Poor responders who transfer their embryos on blast stage on day 5/6
Other: Blast stage transfer
transferring embryos through ICSI procedures for poor responders on blast stage of embryonic development.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: 6 weeks of pregnancy
Percentage of the implanted embryos number for each group / number of transferred embryos.
6 weeks of pregnancy
Live birth rate
Time Frame: delivery of healthy neonate after 37 weeks of pregnancy
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: after 6 weeks of embryonic transfer
Percentage of pregnant cases with fetal heart / transferred cases for each group
after 6 weeks of embryonic transfer
Cancellation rate
Time Frame: 5:6 days of ICSI
percentage of blast transfer cases who did not achieve blast stage (cancelled cases) / total number of blast stage cases
5:6 days of ICSI
Fertilization rate
Time Frame: 16:19 hours after intracytoplasmic injection(ICSI)
Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
16:19 hours after intracytoplasmic injection(ICSI)
Cleavage rate
Time Frame: 72 hours after ICSI
Percentage of cleaved embryos / Number of fertilized oocytes
72 hours after ICSI
High quality day 3 embryos
Time Frame: 72 hours after ICSI
High quality D3 embryos according to Gardner's criteria / total cleaved embryos
72 hours after ICSI
Blast rate
Time Frame: 5:6 days of ICSI
Percentage of total blastocysts / Total cleaved embryos
5:6 days of ICSI
High quality blast rate
Time Frame: 5:6 days of ICSI
Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos.
5:6 days of ICSI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ganin Fertility Center

Investigators

  • Principal Investigator: Manar Hozyen, MSc., Ganin Fertility Center
  • Principal Investigator: Amira Hassan, BSc., Ganin Fertility Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

March 1, 2022

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (ACTUAL)

July 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH0003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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