Early Embryo Cleavage And Multiple Pregnancies After ICSI

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

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Procedure: transfer early cleavage embryos; Procedure: transfer non early cleavage embryo

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
multiple pregnancy	8 weeks

Collaborators and Investigators

• 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

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: Infertility
• Other Study ID Numbers: u12345