Mild Stimulation Protocol Versus Microdose Gonadotropin-releasing Hormone Agonist Flare up Protocol in Poor Responders
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|ClinicalTrials.gov Identifier: NCT01213147|
Recruitment Status : Completed
First Posted : October 1, 2010
Last Update Posted : October 1, 2010
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|
|Intervention Model:||Parallel Assignment|
|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|
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
50 µg Subcutaneous twice a day from cycle day 2 of menstrual cycle
- clinical pregnancy rate [ Time Frame: until 12th gestational week ]
- and implantation rate [ Time Frame: until 12th gestational week ]
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 ClinicalTrials.gov identifier (NCT number): NCT01213147
|Iran, Islamic Republic of|
|Yazd Research and Clinical Center for Infertility|
|Yazd, Iran, Islamic Republic of, 8916877391|
|Principal Investigator:||Mehri Mashayekhy, infertility fellowship||Yazd Research and Clinical Centre for Infertility|