Clinical trial NCT02431689: Delayed Embryo Transfer in Poor Responders
Official title: Antagonist and Short Protocols in Invitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) Cycles With Delayed Embryo Transfer in Poor Ovarian Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Nile Ivf Center, Cairo, Egypt
name: Kamal Shaeer center of infertility
First posted: 2015-05-01
Enrollment: 400
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  1. Advanced maternal age (≥40 years) or any other risk factor for POR;
  2. A previous POR (≤3 oocytes with a conventional stimulation protocol);
  3. 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.

Primary outcomes:
measure: Number of Metaphase II (MII) oocytes
timeFrame: 9-14 days from stimulation
measure: Number of good embryos
timeFrame: 3-5 days after ovum pickup
Secondary outcomes:
measure: chemical pregnancy rate
timeFrame: 14 days after embryo transfer
measure: clinical pregnancy rate
timeFrame: 5 weeks after embryo transfer
measure: Implantation rate
timeFrame: 5 weeks after embryo transfer
measure: Early miscarriage rate
timeFrame: 3 months
measure: Ongoing pregnancy rate
timeFrame: 3 months
measure: Live birth rate
timeFrame: 9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
city: Giza
country: Egypt
facility: Kamal Shaeer center of infertility
city: Giza
country: Egypt
facility: Nile IVF center
Study officials:
affiliation: Cairo University
name: Iman K Shaeer, MD
role: STUDY_DIRECTOR
References: