Early Embryo Cleavage And Multiple Pregnancies After ICSI

NCT ID: NCT02265055

Last Updated: 2014-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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transfer early cleavage embryos (EC)

transfer early cleavage embryos

Group Type ACTIVE_COMPARATOR

transfer early cleavage embryos

Intervention Type PROCEDURE

transfer early cleavage embryos

transfer non early cleavage embryo (NEC)

transfer non early cleavage embryos

Group Type ACTIVE_COMPARATOR

transfer non early cleavage embryo

Intervention Type PROCEDURE

Interventions

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transfer early cleavage embryos

transfer early cleavage embryos

Intervention Type PROCEDURE

transfer non early cleavage embryo

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Edessy Mahmoud

Obstetrics and Gynecology Department, faculty of medicine (Assiut)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mahmoud edessy, prof

Role: STUDY_DIRECTOR

Al-Azhar University

abd elnasr m ali, prof

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

ahmed fata, prof

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

wael hamed, dr

Role: STUDY_CHAIR

Al-Azhar University

Other Identifiers

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u12345

Identifier Type: -

Identifier Source: org_study_id

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