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Early Embryo Cleavage And Multiple Pregnancies After ICSI

A

Al-Azhar University

Status and phase

Completed
Phase 2
Phase 1

Conditions

Infertility

Treatments

Procedure: transfer non early cleavage embryo
Procedure: transfer early cleavage embryos

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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).

Enrollment

193 patients

Sex

Female

Ages

Under 35 years old

Volunteers

No 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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

193 participants in 2 patient groups

transfer early cleavage embryos (EC)
Active Comparator group
Description:
transfer early cleavage embryos
Treatment:
Procedure: transfer early cleavage embryos
transfer non early cleavage embryo (NEC)
Active Comparator group
Description:
transfer non early cleavage embryos
Treatment:
Procedure: transfer non early cleavage embryo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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