Skip to main content
Clinical Trials/NCT02431689
NCT02431689
Completed
Not Applicable

Antagonist and Short Protocols in Invitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) Cycles With Delayed Embryo Transfer in Poor Ovarian Response

Cairo University3 sites in 1 country400 target enrollmentApril 2015
ConditionsInfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
Cairo University
Enrollment
400
Locations
3
Primary Endpoint
Number of good embryos
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Poor ovarian response indicates inadequate ovarian response to ovarian stimulation. In the current study the investigators will attempt to compare antagonist and short protocols regarding oocyte as well as embryo quantity and quality. Frozen embryo transfer will be performed in order to abolish iatrogenic effect of stimulation drugs on implantation. Still implantation and pregnancy rates are considered secondary outcomes.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
May 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yasmin Ahmed Bassiouny

Dr

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Patient selection is based on the ESHRE consensus group 2011 definition of poor ovarian response (POR) (Bologna criteria):
  • At least two of the following three features must be present:
  • Advanced maternal age (≥40 years) or any other risk factor for POR;
  • A previous POR (≤3 oocytes with a conventional stimulation protocol);
  • An abnormal ovarian reserve test (i.e. Antral follicle count (AFC) \<5-7 follicles or Antimullerian hormone (AMH) \<0.5-1.1 ng/ml).
  • Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal Ovarian reserve test (ORT). By definition, the term POR refers to the ovarian response and, therefore, one stimulated cycle is considered essential for the diagnosis of POR. However, patients over 40 years of age with an abnormal ORT may be classified as poor responders since both advanced age and an abnormal ORT may indicate reduced ovarian reserve and act as a surrogate of ovarian stimulation cycle. In this case, the patients should be more properly defined as expected PORs.

Exclusion Criteria

  • Women with endometriosis, endocrinal problems, uterine abnormalities as well as male azospermia.

Outcomes

Primary Outcomes

Number of good embryos

Time Frame: 3-5 days after ovum pickup

the number of good quality embryos obtained from each patient

Number of Metaphase II (MII) oocytes

Time Frame: 9-14 days from stimulation

Number of MII oocytes collected from each patient on the day of ovum pickup (OPU)

Secondary Outcomes

  • clinical pregnancy rate(5 weeks after embryo transfer)
  • Implantation rate(5 weeks after embryo transfer)
  • Live birth rate(9 months)
  • chemical pregnancy rate(14 days after embryo transfer)
  • Ongoing pregnancy rate(3 months)
  • Early miscarriage rate(3 months)

Study Sites (3)

Loading locations...

Similar Trials