Does Transfer of Poor-quality Embryos With Good-quality Embryos Improve Pregnancy Outcome in Women Undergoing IVF/ICSI?

Women planned to undergo blastocyst-stage embryo transfer after IVF/ICSI were randomized into 2 groups:

• group I: women who had only good-quality embryo transfer.
• group II: women who had both good-quality and poor-quality embryo transfer.

primary outcome was ongoing clinical pregnancy rate

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Embryo transfer

• Study Type: Interventional
• Enrollment (Actual): 627
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women undergoing primary IVF/ICSI cycles for tubal factor/unexplained infertility and had blastocyst-stage ET

Exclusion Criteria:

• cleavage-stage ET.
• women who had no good-quality embryos to transfer
• women who had known poor endometrial receptivity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Good-quality embryo transfer; Women who had only good-quality embryo transfer	Other: Embryo transfer; Transfer of different qualities of embryos at blastocyst stage
Active Comparator: good- and poor-quality embryo transfer; Women who had both good- and poor-quality embryo transfer	Other: Embryo transfer; Transfer of different qualities of embryos at blastocyst stage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing clinical pregnancy rate	viable intrauterine pregnancy ongoing beyond 12 weeks of gestation	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical pregnancy rate	positive serum hCG	2 weeks after ET
Clinical pregnancy rate	sonographic detection of viable intrauterine gestational sac	4 weeks after ET
Multiple pregnancy rate	No. of intrauterine gestational sacs	4-6 weeks after ET
Ectopic pregnancy rate	Extrauterine pregnancy	6 weeks after ET

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: Dar El Teb Institute
• Investigators: Principal Investigator: Mohammed Faris, MD, Dar El Teb IVF and Infertility Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: DAT-055

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No