Delayed Embryo Transfer in Poor Responders

Not Applicable

Completed

• Conditions: Infertility

• Registration Number: NCT02431689
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-01
• Status Verified: 2018-05
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-12
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of good embryos	3-5 days after ovum pickup	the number of good quality embryos obtained from each patient
Number of Metaphase II (MII) oocytes	9-14 days from stimulation	Number of MII oocytes collected from each patient on the day of ovum pickup (OPU)

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy rate	5 weeks after embryo transfer	the detection of intrauterine gestational sac with positive pulsations
Implantation rate	5 weeks after embryo transfer	the ratio between the number of embryos transferred and the number of sacs
Live birth rate	9 months	Pregnancy ending with a live birth
Early miscarriage rate	3 months	Pregnancy loss in the first 12 weeks gestation
chemical pregnancy rate	14 days after embryo transfer	positive serum Beta HCG 14 days after embryo transfer
Ongoing pregnancy rate	3 months	Pregnancy ongoing beyond 12 weeks gestation

Trial Locations

Locations (3)

IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini); 🇪🇬 Cairo, Egypt

Kamal Shaeer center of infertility; 🇪🇬 Giza, Egypt

Nile IVF center; 🇪🇬 Giza, Egypt