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

This study has been completed.
Yazd Research & Clinical Center for Infertility
Information provided by:
Yazd Medical University Identifier:
First received: September 30, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

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 Intervention Phase
Pregnancy Drug: clomiphene citrate Drug: buserelin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Yazd Medical University:

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

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

Enrollment: 159
Study Start Date: April 2009
Study Completion Date: May 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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 )
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Dr Mehri Mashayekhy, Yazd Research and Clinical centre for infertility Identifier: NCT01213147     History of Changes
Other Study ID Numbers: 2063
Study First Received: September 30, 2010
Last Updated: September 30, 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 processed this record on September 21, 2017