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

This study has been completed.
Sponsor:
Collaborator:
Yazd Research & Clinical Center for Infertility
Information provided by:
Yazd Medical University
ClinicalTrials.gov Identifier:
NCT01213147
First received: September 30, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • and implantation rate [ Time Frame: until 12th gestational week ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   38 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01213147

Locations
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
Investigators
Principal Investigator: Mehri Mashayekhy, infertility fellowship Yazd Research and Clinical Centre for Infertility
  More Information

No publications provided

Responsible Party: Dr Mehri Mashayekhy, Yazd Research and Clinical centre for infertility
ClinicalTrials.gov Identifier: NCT01213147     History of Changes
Other Study ID Numbers: 2063
Study First Received: September 30, 2010
Last Updated: September 30, 2010
Health Authority: Iran: Ethics Committee

Keywords provided by Yazd Medical University:
Pregnancy
Clomiphene Citrate
Fertilization
Buserelin

Additional relevant MeSH terms:
Buserelin
Clomiphene
Citric Acid
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anticoagulants
Hematologic Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on July 23, 2014