Early Embryo Cleavage And Multiple Pregnancies After ICSI

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02265055

Enrollment

193

Registered

2014-10-15

Start date

2010-12-31

Completion date

2012-12-31

Last updated

2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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).

Interventions

PROCEDUREtransfer early cleavage embryos

transfer early cleavage embryos

PROCEDUREtransfer non early cleavage embryo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 35 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
clinical pregnancy	6 weeks

Secondary

Measure	Time frame
multiple pregnancy	8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026