Optimal Embryonic Stage for Transfer in Poor Responders

• Conditions: Poor Response to Ovulation Induction; Infertility, Female
• Interventions: Other: Cleavage stage transfer; Other: Blast stage transfer

• Registration Number: NCT04485819
• Lead Sponsor: Ganin Fertility Center

Brief Summary

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

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 Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Last Update Submitted: 2020-07-22
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24
• Primary Completion: 2021-12-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cleavage stage transfer	Cleavage stage transfer	Poor responders who transfer their embryos in cleavage stage on day 3
Blast stage transfer	Blast stage transfer	Poor responders who transfer their embryos on blast stage on day 5/6

Primary Outcome Measures

Name	Time	Method
Live birth rate	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.
Implantation rate	6 weeks of pregnancy	Percentage of the implanted embryos number for each group / number of transferred embryos.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ganin fertility center; 🇪🇬 Cairo, Egypt