Recombinant FSH Compared to Clomiphene Citrate as the First-Line in Ovulation Induction in Polycystic Ovary Syndrome Using Newly Designed Pens: A Randomized Controlled Trial
Objective: Since there is still controversy regarding the best first-line choice for ovulation induction (OI) other than clomiphene citrate (CC) in infertile women diagnosed with polycystic ovary syndrome (PCOS), the aim of the present study was to compare recombinant human FSH with CC as the first...
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Tehran University of Medical Sciences
2016-05-01
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doaj-2ce343b7843542e2a898d4a220dd10832021-04-02T12:31:14ZengTehran University of Medical SciencesJournal of Family and Reproductive Health1735-89491735-93922016-05-01101346Recombinant FSH Compared to Clomiphene Citrate as the First-Line in Ovulation Induction in Polycystic Ovary Syndrome Using Newly Designed Pens: A Randomized Controlled TrialBatool Hossein-Rashidi0Bahareh Khandzad1Ensieh Shahrokh-Tehraninejad2Maryam Bagheri3Mansoureh Gorginzadeh4Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, IranReproductive Health Research Center, Tehran University of Medical Sciences, Tehran, IranReproductive Health Research Center, Tehran University of Medical Sciences, Tehran, IranReproductive Health Research Center, Tehran University of Medical Sciences, Tehran, IranTehran University of Medical Sciences, Tehran, IranObjective: Since there is still controversy regarding the best first-line choice for ovulation induction (OI) other than clomiphene citrate (CC) in infertile women diagnosed with polycystic ovary syndrome (PCOS), the aim of the present study was to compare recombinant human FSH with CC as the first course of OI in these women. Materials and methods: In this pilot randomized controlled trial, 104 infertile women diagnosed with PCOS were randomized in two groups to receive either CC with the dose of 100mg per day from day 3 of a spontaneous or progestin-induced menstruation for 5 days or rFSH with the starting dose of 50 IU daily {and weekly dose increment of as low as 12.5 IU}, on the day4 of the cycle. They were assessed during a single OI course. The pregnancy rate (PR) and live birth rate (LBR) were the primary outcomes. The follicular response, endometrial thickness, cancellation of the cycles and ovarian hyper stimulation (OHSS) rate were the secondary outcomes. Results: Analyzing data of 96 patients using Chi2 and Fischer’s Exact test (44 in rFSH group and 52 in CC group), both PR and LBR were comparable in the two groups {13.6% vs. 9.6% and 11.4% vs. 9.6% respectively}, with the difference not to be significant (p > 0.05). No cases of OHSS or multiple gestations happened during the treatment course. Conclusion: It seems that rFSH is as efficacious as CC while not with more complications for the first-line OI in infertile women with PCOS. However, due to the limitations of the present study including the small population and the single cycle of treatment, our results did not come out to prove this and more studies with larger study population are needed to compare the cumulative PR and LBR. https://jfrh.tums.ac.ir/index.php/jfrh/article/view/411Polycystic Ovary SyndromeClomiphene CitrateRecombinant FSHOvulation Induction |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Batool Hossein-Rashidi Bahareh Khandzad Ensieh Shahrokh-Tehraninejad Maryam Bagheri Mansoureh Gorginzadeh |
spellingShingle |
Batool Hossein-Rashidi Bahareh Khandzad Ensieh Shahrokh-Tehraninejad Maryam Bagheri Mansoureh Gorginzadeh Recombinant FSH Compared to Clomiphene Citrate as the First-Line in Ovulation Induction in Polycystic Ovary Syndrome Using Newly Designed Pens: A Randomized Controlled Trial Journal of Family and Reproductive Health Polycystic Ovary Syndrome Clomiphene Citrate Recombinant FSH Ovulation Induction |
author_facet |
Batool Hossein-Rashidi Bahareh Khandzad Ensieh Shahrokh-Tehraninejad Maryam Bagheri Mansoureh Gorginzadeh |
author_sort |
Batool Hossein-Rashidi |
title |
Recombinant FSH Compared to Clomiphene Citrate as the First-Line in Ovulation Induction in Polycystic Ovary Syndrome Using Newly Designed Pens: A Randomized Controlled Trial |
title_short |
Recombinant FSH Compared to Clomiphene Citrate as the First-Line in Ovulation Induction in Polycystic Ovary Syndrome Using Newly Designed Pens: A Randomized Controlled Trial |
title_full |
Recombinant FSH Compared to Clomiphene Citrate as the First-Line in Ovulation Induction in Polycystic Ovary Syndrome Using Newly Designed Pens: A Randomized Controlled Trial |
title_fullStr |
Recombinant FSH Compared to Clomiphene Citrate as the First-Line in Ovulation Induction in Polycystic Ovary Syndrome Using Newly Designed Pens: A Randomized Controlled Trial |
title_full_unstemmed |
Recombinant FSH Compared to Clomiphene Citrate as the First-Line in Ovulation Induction in Polycystic Ovary Syndrome Using Newly Designed Pens: A Randomized Controlled Trial |
title_sort |
recombinant fsh compared to clomiphene citrate as the first-line in ovulation induction in polycystic ovary syndrome using newly designed pens: a randomized controlled trial |
publisher |
Tehran University of Medical Sciences |
series |
Journal of Family and Reproductive Health |
issn |
1735-8949 1735-9392 |
publishDate |
2016-05-01 |
description |
Objective: Since there is still controversy regarding the best first-line choice for ovulation induction (OI) other than clomiphene citrate (CC) in infertile women diagnosed with polycystic ovary syndrome (PCOS), the aim of the present study was to compare recombinant human FSH with CC as the first course of OI in these women.
Materials and methods: In this pilot randomized controlled trial, 104 infertile women diagnosed with PCOS were randomized in two groups to receive either CC with the dose of 100mg per day from day 3 of a spontaneous or progestin-induced menstruation for 5 days or rFSH with the starting dose of 50 IU daily {and weekly dose increment of as low as 12.5 IU}, on the day4 of the cycle. They were assessed during a single OI course. The pregnancy rate (PR) and live birth rate (LBR) were the primary outcomes. The follicular response, endometrial thickness, cancellation of the cycles and ovarian hyper stimulation (OHSS) rate were the secondary outcomes.
Results: Analyzing data of 96 patients using Chi2 and Fischer’s Exact test (44 in rFSH group and 52 in CC group), both PR and LBR were comparable in the two groups {13.6% vs. 9.6% and 11.4% vs. 9.6% respectively}, with the difference not to be significant (p > 0.05). No cases of OHSS or multiple gestations happened during the treatment course.
Conclusion: It seems that rFSH is as efficacious as CC while not with more complications for the first-line OI in infertile women with PCOS. However, due to the limitations of the present study including the small population and the single cycle of treatment, our results did not come out to prove this and more studies with larger study population are needed to compare the cumulative PR and LBR.
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topic |
Polycystic Ovary Syndrome Clomiphene Citrate Recombinant FSH Ovulation Induction |
url |
https://jfrh.tums.ac.ir/index.php/jfrh/article/view/411 |
work_keys_str_mv |
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