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OpenTrials
Completed

NCT Number: NCT02265055

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.

Completed

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Key information

Age range

Up to 35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transfer early cleavage embryos

Procedure

transfer early cleavage embryos

transfer non early cleavage embryo

Procedure

Primary outcomes

  1. clinical pregnancy

    Time frame: 6 weeks

Secondary outcomes

  1. multiple pregnancy

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 15, 2014
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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