Early Embryo Cleavage And Multiple Pregnancies After ICSI

Phase 1

Completed

• Conditions: Infertility
• Interventions: Procedure: transfer early cleavage embryos; Procedure: transfer non early cleavage embryo

• Registration Number: NCT02265055
• Lead Sponsor: Al-Azhar University

Brief Summary

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

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 Timeline

• Study Start: 2010-12
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2014-10
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-09
• Last Update Submitted: 2014-10-09
• Study First Posted: 2014-10-15
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 193

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transfer early cleavage embryos (EC)	transfer early cleavage embryos	transfer early cleavage embryos
transfer non early cleavage embryo (NEC)	transfer non early cleavage embryo	transfer non early cleavage embryos

Primary Outcome Measures

Name	Time	Method
clinical pregnancy	6 weeks

Secondary Outcome Measures

Name	Time	Method
multiple pregnancy	8 weeks