Optimal Embryonic Stage for Transfer in Poor Responders

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04485819
• Other study ID #: MH0003
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2020
• Source: Ganin Fertility Center
• Contact: Manar M Hozyen, MSc.
• Phone: +2001229483320
• Email: manarnrc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Poor Response to Ovulation Induction

Intervention

Other:
• Cleavage stage transfer
transferring embryos through ICSI procedures for poor responders on cleavage stage of embryonic development.
• Blast stage transfer
transferring embryos through ICSI procedures for poor responders on blast stage of embryonic development.

Locations

Country	Name	City	State
Egypt	Ganin fertility center	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ganin Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Implantation rate	Percentage of the implanted embryos number for each group / number of transferred embryos.	6 weeks of pregnancy
Secondary	Clinical pregnancy rate	Percentage of pregnant cases with fetal heart / transferred cases for each group	after 6 weeks of embryonic transfer
Secondary	Cancellation rate	percentage of blast transfer cases who did not achieve blast stage (cancelled cases) / total number of blast stage cases	5:6 days of ICSI
Secondary	Fertilization rate	Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes	16:19 hours after intracytoplasmic injection(ICSI)
Secondary	Cleavage rate	Percentage of cleaved embryos / Number of fertilized oocytes	72 hours after ICSI
Secondary	High quality day 3 embryos	High quality D3 embryos according to Gardner's criteria / total cleaved embryos	72 hours after ICSI
Secondary	Blast rate	Percentage of total blastocysts / Total cleaved embryos	5:6 days of ICSI
Secondary	High quality blast rate	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