Mild Stimulation Protocol Versus Microdose Gonadotropin-releasing Hormone Agonist Flare up Protocol in Poor Responders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01213147
Recruitment Status : Completed
First Posted : October 1, 2010
Last Update Posted : October 1, 2010
Yazd Research & Clinical Center for Infertility
Information provided by:
Yazd Medical University

Brief Summary:

Despite the progression in assisted reproductive technology (ART), the preferred protocol for poor responders is still controversial. The management of poor responders consists of 10% of ART cycles .

The response to controlled ovarian hyperstimulation (COH) is lower regarding estradiol level , number of obtained oocytes , and fertilization , implantation and pregnancy rates in patients with low ovarian reserve . Furthermore , bad quality embryos are observed in these women more than normoresponders and the increase of cancellation rate and doses of gonadotropin administration are remarkable results in poor responders . Several criteria have introduced for poor responders , the main defect in the management of them is lack of specific definition .Several strategies are available to improve ART cycles outcome in poor responders. These modalities include using : high FSH dose , stop GnRH-agonist protocol , addition of growth hormone , transdermal testosterone , aromatase inhibitor , GnRH-antagonist and recombinant FSH ( r-FSH) ; while the improvement of pregnancy rate has been quite low.

The most common used protocol for ovarian stimulation is microdose GnRH-agonist flare in poor responders .Some investigators concluded that the use of GnRH-agonist " even in lower doses , led to prolonged stimulation and increased the cost without improving IVF outcome. Furthermore this method increased LH , progesterone and androgen of serum in follicular phase , which caused deleterious effect on follicular growth and oocyte quality .

Clomiphene citrate co-treatment with gonadotropin and antagonist are one of the recommended protocol in poor responders . Clomiphene citrate increases endogenous FSH versus agonist in microdose protocol. Decreasing the doses of used gonadotropin and duration of stimulation are its beneficial effects in COH cycle .

The aim of this study was comparing CC/gonadotropin/antagonist and GnRH agonist flare protocols on IVF outcome in poor responders .

Condition or disease Intervention/treatment Phase
Pregnancy Drug: clomiphene citrate Drug: buserelin Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Use of Mild Stimulation Protocol in Poor Responders : a Randomized Trial
Study Start Date : April 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: clomiphene citrate,pregnancy,poor responders
Woman in clomiphene citrate arm are administered 100mg/day oral from day 3 of menstrual cycle until day 7 of cycle
Drug: clomiphene citrate
100 mg per day oral for 7 days

Active Comparator: buserelin,pregnancy,poor responder
women in control arm are administered Buserelin buserelin 50 µg SC twice a day from cycle day 2 of menstrual cycle
Drug: buserelin
50 µg Subcutaneous twice a day from cycle day 2 of menstrual cycle

Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: until 12th gestational week ]

Secondary Outcome Measures :
  1. and implantation rate [ Time Frame: until 12th gestational week ]

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Ages Eligible for Study:   38 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women with ≥38 years old
  • women who had one or more previous failed IVF cycles in which three or fewer oocyte were been retrieved and/or serum E2 level on the day of hCG administration was ≤500 pg/ml were enrolled in this study

Exclusion Criteria:

  • BMI > 30
  • endocrine disorders
  • metabolic disorders
  • history of ovarian surgery
  • sever endometriosis
  • sever male factor ( azospermia )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01213147

Iran, Islamic Republic of
Yazd Research and Clinical Center for Infertility
Yazd, Iran, Islamic Republic of, 8916877391
Sponsors and Collaborators
Yazd Medical University
Yazd Research & Clinical Center for Infertility
Principal Investigator: Mehri Mashayekhy, infertility fellowship Yazd Research and Clinical Centre for Infertility

Responsible Party: Dr Mehri Mashayekhy, Yazd Research and Clinical centre for infertility Identifier: NCT01213147     History of Changes
Other Study ID Numbers: 2063
First Posted: October 1, 2010    Key Record Dates
Last Update Posted: October 1, 2010
Last Verified: September 2010

Keywords provided by Yazd Medical University:
Clomiphene Citrate

Additional relevant MeSH terms:
Citric Acid
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators