NCT03113097

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
627

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Status
completed

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

June 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

2.5 years

First QC Date

April 10, 2017

Last Update Submit

April 10, 2017

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Ongoing clinical pregnancy rate

    viable intrauterine pregnancy ongoing beyond 12 weeks of gestation

    12 weeks

Secondary Outcomes (4)

  • Biochemical pregnancy rate

    2 weeks after ET

  • Clinical pregnancy rate

    4 weeks after ET

  • Multiple pregnancy rate

    4-6 weeks after ET

  • Ectopic pregnancy rate

    6 weeks after ET

Study Arms (2)

Good-quality embryo transfer

ACTIVE COMPARATOR

Women who had only good-quality embryo transfer

Other: Embryo transfer

good- and poor-quality embryo transfer

ACTIVE COMPARATOR

Women who had both good- and poor-quality embryo transfer

Other: Embryo transfer

Interventions

Embryo transferOTHER

Transfer of different qualities of embryos at blastocyst stage

Good-quality embryo transfergood- and poor-quality embryo transfer

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Interventions

Embryo Transfer

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Mohammed Faris, MD

    Dar El Teb IVF and Infertility Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Mohammed Faris

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 13, 2017

Study Start

June 1, 2014

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

April 13, 2017

Record last verified: 2017-04