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Completed

NCT Number: NCT02431689

Delayed Embryo Transfer in Poor Responders

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.

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Key information

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

IVF/ICSI

Procedure

controlled ovarian hyperstimulation with various protocols, follow up till stimulated follicles measure from 18-20 mm, then ovum pickup followed by embryo transfer is done.

Primary outcomes

  1. 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)

  2. Number of good embryos

    Time frame: 3-5 days after ovum pickup

    the number of good quality embryos obtained from each patient

Secondary outcomes

  1. chemical pregnancy rate

    Time frame: 14 days after embryo transfer

    positive serum Beta HCG 14 days after embryo transfer

  2. clinical pregnancy rate

    Time frame: 5 weeks after embryo transfer

    the detection of intrauterine gestational sac with positive pulsations

  3. Implantation rate

    Time frame: 5 weeks after embryo transfer

    the ratio between the number of embryos transferred and the number of sacs

  4. Early miscarriage rate

    Time frame: 3 months

    Pregnancy loss in the first 12 weeks gestation

  5. Ongoing pregnancy rate

    Time frame: 3 months

    Pregnancy ongoing beyond 12 weeks gestation

  6. Live birth rate

    Time frame: 9 months

    Pregnancy ending with a live birth

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Kamal Shaeer center of infertility
  • Nile Ivf Center, Cairo, Egypt

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 1, 2015
Registry last updated
May 15, 2018

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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