Early Embryo Cleavage And Multiple Pregnancies After ICSI

October 9, 2014 updated by: Edessy Mahmoud, Al-Azhar University
To observe whether Number of early cleavage embryos can be a predictor for multiple pregnancies after ICSI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 193 infertile couples, attending the ART unit, International Islamic Center for Population Studies and Research (IICPSR), -Al- Azhar University in the period from December 2010 to September 2012, were included in this study.

The controlled ovarian hyperstimulation protocol was performed according to a long GnRH agonist protocol starting in the midluteal phase (day 21) of the preceding cycle. Embryos were assessed at 25 - 27 hr after ICSI for early cleavage. Embryos which reached the two cell stage at this interval were classified as Early Cleavage (EC) embryos, and the remaining as Non Early Cleavage (NEC) embryos. Embryos were assessed again at 64 - 68 hours post-ICSI for day-three embryo morphology. Day 3 embryo transfer was done. The best two or three embryos, according to day 3 embryo morphology were transferred. The patients were subdivided into two subgroups; one will transfer early cleavage embryos (EC) and the other will transfer non early cleavage embryo (NEC).

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: transfer early cleavage embryos (EC)
transfer early cleavage embryos
Procedure: transfer early cleavage embryos
transfer early cleavage embryos
Active Comparator: transfer non early cleavage embryo (NEC)
transfer non early cleavage embryos
Procedure: transfer non early cleavage embryo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical pregnancy
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
multiple pregnancy
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Study Director: mahmoud edessy, prof, Alazhar University
  • Principal Investigator: abd elnasr m ali, prof, Alazhar University
  • Principal Investigator: ahmed fata, prof, Alazhar University
  • Study Chair: wael hamed, dr, Alazhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • u12345

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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