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