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Completed

NCT Number: NCT01006954

Outcome of Two Protocols in Poor Responders in Assisted Reproductive Technology (ART) Cycle

About 9 to 24 % of women undergoing in vitro fertilization (IVF) treatment respond poorly to the usual gonadotrophin stimulation protocol applied. Several induction ovulation treatments have been suggested for increasing pregnancy rate. In this study, the investigators will compare the outcome of Microflare protocol and Flare up regimen in poor responders.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

30 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

1- Endocrinology and Female Infertility Department, Reproductive Medicine Research Centre, Royan Institute, ACECR

Tehran, 14114, Iran

About this study

In this randomized clinical trial study, a total of 200 infertile women with poor ovarian response who undergo IVF / ICSI treatment cycle at Royan Institute will enroll in this study and will randomly be divided into two groups of 100 patients. This study has been approved by Royan ethics committee and written consent will be obtained from each patient.

The patients will be randomized to one of two groups of Flare Up or Microdose GnRh agonist flare up.

Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), Estradiol, will be evaluated on day 2 or 3 and when follicle size become >14.

2 weeks after embryo transfer, the patients will be tested for serum β-hCG for assessing the pregnancy. The clinical pregnancy will be clarified by the number of women with gestational sacs on transvaginal sonography at 4-6 weeks of gestation. In the calculation of implantation, the number of gestational sacs will be considered.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Poor responders (Presence of at least two of following items is necessary for inclusion to the study)

  • History of Cycle Cancellation
  • History of oocyte number 3 (in previous cycle)
  • History of Number of antral follicle < 5 in previous cycle
  • Age≥38
  • FSH>12 on day 2 or 3
  • Ovarian Volume 3 cm3

Exclusion criteria

  • Male factor (azospermi)
  • Myoma ≥6cm
  • One way ovary
  • Tumor or cyst >13mm
  • Age >42

Treatment and study plan

Microdose GnRh

Drug

Microflare protocol in poor responders for IVF/ICSI

Other names: Case

Flare up

Drug

Flare up protocol in poor responders for IVF/ICSI

Other names: Standard treatment

Primary outcomes

  1. Live birth rate

    Time frame: 12 months

Secondary outcomes

  1. Cycle cancellation rates

    Time frame: 12 Months

  2. Number of oocytes generated

    Time frame: 12 Months

  3. Number of embryos generated

    Time frame: 12 Months

  4. Implantation rate

    Time frame: 12 Months

  5. Pregnancy rate

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

Comparison of Micro Dose Gonadotropin-Releasing Hormone (GnRH) Agonist Flare up & Flare Protocol in Poor Responders in Assisted Reproductive Technology (ART) Cycle

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 3, 2009
Registry last updated
Dec 19, 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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