NCT02265055

Brief Summary

To observe whether Number of early cleavage embryos can be a predictor for multiple pregnancies after ICSI.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
193

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2010

Typical duration for phase_1

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

December 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

1.8 years

First QC Date

October 9, 2014

Last Update Submit

October 9, 2014

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy

    6 weeks

Secondary Outcomes (1)

  • multiple pregnancy

    8 weeks

Study Arms (2)

transfer early cleavage embryos (EC)

ACTIVE COMPARATOR

transfer early cleavage embryos

Procedure: transfer early cleavage embryos

transfer non early cleavage embryo (NEC)

ACTIVE COMPARATOR

transfer non early cleavage embryos

Procedure: transfer non early cleavage embryo

Interventions

transfer early cleavage embryosPROCEDURE

transfer early cleavage embryos

transfer early cleavage embryos (EC)
transfer non early cleavage embryoPROCEDURE
transfer non early cleavage embryo (NEC)

Eligibility Criteria

AgeUp to 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • BMI \>25 - 30 kg/m2
  • Have two ovaries
  • Regular cycles
  • first ICSI cycle
  • Long midluteal GnRH protocol.

You may not qualify if:

  • uterine factor as a cause of female factor infertility
  • pelvic masses or diseases (e.g: endometriosis, fibroids, hydrosalpnix, ...)
  • history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...)
  • azoospermia as a cause of male factor infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • mahmoud edessy, prof

    Al-Azhar University

    STUDY DIRECTOR

  • abd elnasr m ali, prof

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

  • ahmed fata, prof

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

  • wael hamed, dr

    Al-Azhar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetrics and Gynecology Department, faculty of medicine (Assiut)

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 15, 2014

Study Start

December 1, 2010

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

October 15, 2014

Record last verified: 2014-10