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Early gonadotropin-releasing hormone antagonist protocol in women with polycystic ovary syndrome: A preliminary randomized trial.

ABSTRACT: Objective:To prospectively evaluate the efficacy and safety of a fixed early gonadotropin-releasing hormone (GnRH) antagonist protocol compared to a conventional midfollicular GnRH antagonist protocol and a long GnRH agonist protocol for in vitro fertilization (IVF) in patients with polycystic ovary syndrome (PCOS). Methods:Randomized patients in all three groups (early antagonist, n=14; conventional antagonist, n=11; long agonist, n=11) received 21 days of oral contraceptive pill treatment prior to stimulation. The GnRH antagonist was initiated on the 1st day of stimulation in the early antagonist group and on the 6th day in the conventional antagonist group. The GnRH agonist was initiated on the 18th day of the preceding cycle. The primary endpoint was the number of oocytes retrieved, and the secondary endpoints included the rate of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) and the clinical pregnancy rate. Results:The median total number of oocytes was similar among the three groups (early, 16; conventional, 12; agonist, 19; p=0.111). The early GnRH antagonist protocol showed statistically non-significant associations with a higher clinical pregnancy rate (early, 50.0%; conventional, 11.1%; agonist, 22.2%; p=0.180) and lower incidence of moderate-to-severe OHSS (early, 7.7%; conventional, 18.2%; agonist, 27.3%; p=0.463), especially among subjects at high risk for OHSS (early, 12.5%; conventional, 40.0%; agonist, 50.0%; p=0.324). Conclusion:In PCOS patients undergoing IVF, early administration of a GnRH antagonist may possibly lead to benefits due to a reduced incidence of moderate-to-severe OHSS in high-risk subjects with a better clinical pregnancy rate per embryo transfer. Further studies with more subjects are required.

SUBMITTER: Shin JJ

PROVIDER: S-EPMC6125151 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Early gonadotropin-releasing hormone antagonist protocol in women with polycystic ovary syndrome: A preliminary randomized trial.

Shin Jae Jun JJ Park Kyung Eui KE Choi Young Min YM Kim Hye-Ok HO Choi Dong-Hee DH Lee Woo Sik WS Cho Jung-Hyun JH

Clinical and experimental reproductive medicine 20180903 3

<h4>Objective</h4>To prospectively evaluate the efficacy and safety of a fixed early gonadotropin-releasing hormone (GnRH) antagonist protocol compared to a conventional midfollicular GnRH antagonist protocol and a long GnRH agonist protocol for <i>in vitro</i> fertilization (IVF) in patients with polycystic ovary syndrome (PCOS).<h4>Methods</h4>Randomized patients in all three groups (early antagonist, n=14; conventional antagonist, n=11; long agonist, n=11) received 21 days of oral contracepti ...[more]

PMID: 30202744

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Project description:BackgroundExogenous progestational agents have recently been introduced as an alternative pituitary modulator for the prevention of premature luteinizing hormone (LH) surges during in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) treatments. There is increasing evidence that frozen-embryo transfer (FET) is associated with a lower risk of ovarian hyperstimulation syndrome (OHSS) in women with polycystic ovary syndrome (PCOS). Herein, we compared the clinical outcomes of the progesterone protocol with the gonadotropin releasing hormone antagonist (GnRH-ant) protocol in PCOS patients with a ''freeze-all'' strategy.MethodsIn this prospective single-central randomized controlled trial, a total of 120 PCOS patients undergoing their first IVF/ICSI treatment were randomly assigned to receive the progesterone protocol (study group) or GnRH-ant protocol (control group). The main outcome was the number of oocytes retrieved. Secondary outcomes included the incidence of premature LH rise/surge, the number of viable embryos, and pregnancy outcomes.ResultsThe number of retrieved oocytes (14.65±7.64 versus 12.8±8.57) and viable embryos (5.38±3.54 versus 5.03±3.92) in the study group were comparable to those in the control group (P>0.05). Similarly, no between-group differences were found in the number of mature oocytes, fertilized oocytes, cleaved embryos, and the viable embryo rate per oocyte retrieved (P>0.05). However, the oocyte retrieval rate (66.02%±19.63% versus 54.38%±26.39%) and fertilization rate (78.12%±18.41% versus 62.76%±23.32%) in the study group were significantly more than that in the control group (P<0.05). The mean serum LH value on day 6-7 was lower in the study group than that in the control group (7.47±0.97 versus 3.98±0.52 IU/L, P<0.05), and the incidence of premature LH rise was higher in the study group than in the control group, although no patients experienced premature LH surge. The clinical pregnancy rate [58.82% vs. 57.32%, RR 0.94 (95% CI: 0.508, 1.738), P>0.05] and implantation rate [43.21% vs. 41.4%, RR 0.929 (95% CI: 0.595, 1.448), P>0.05] were also similar between the two groups.ConclusionsThe progesterone protocol is comparable with the GnRH-ant protocol regarding oocyte/embryo yields and the probability of clinical pregnancy in PCOS patients, but the two regimens were distinct in the regulation of pituitary LH secretion.Trial registration numberChictr.org.cn: ChiCTR-IOR-15006633.

Project description:IntroductionMany patients demonstrate an insufficient endogenous luteinising hormone (LH) concentration during ovarian stimulation. With traditional fixed or flexible gonadotropin-releasing hormone (GnRH) antagonist protocols, antagonist administration may further reduce LH activity. Previously, we proved that LH can be used as an indicator for the timing and dosage of antagonist. Patients with a persistently low LH concentration during ovarian stimulation may not require antagonists, whereas antagonist administration can affect reproductive outcomes. To further explore this hypothesis, we designed a randomised clinical trial to compare the LH-based flexible GnRH antagonist protocol with traditional flexible GnRH antagonist protocol in women with normal ovarian response.Methods and analysisThis study was a multicentre, parallel, prospective, randomised, non-inferiority study. The primary efficacy endpoint was cumulative ongoing pregnancy rate per cycle. The study aimed to prove the non-inferiority of cumulative ongoing pregnancy rate per cycle with an LH-based flexible GnRH antagonist protocol versus traditional flexible GnRH antagonist protocol. Secondary endpoints were the high-quality embryo rate, clinical pregnancy rate and cancellation rate. Differences in cost-effectiveness and adverse events were evaluated. The cumulative ongoing pregnancy rate per cycle in women with normal ovarian response was 70%. Considering that a non-inferiority threshold should retain 80% of the clinical effect of a control treatment, a minimal clinical difference of 14% (one-sided: α, 2.5%; β, 20%) and a total of 338 patients were needed. Anticipating a 10% drop-out rate, the total number of patients required was 372.Ethics and disseminationThis trial has been approved by the Institutional Ethical Committee of Beijing Chao-Yang hospital. All participants in the trial will provide written informed consent. The study will be conducted according to the principles outlined in the Declaration of Helsinki and its amendments. Results of this study will be disseminated in peer-reviewed scientific journals.Trial registration numberChiCTR1800018077.

Project description:BackgroundThe main objective of the present work was to compare the effects of the gonadotropin-releasing hormone agonist (GnRH-a) and GnRH antagonist (GnRH-ant) on the gene expression profiles of oocytes obtained from Iranian infertile couples undergoing in vitro fertilization (IVF).MethodsFifty infertile couples who underwent IVF between June 2012 and November 2013 at the Infertility Center of Tehran Women General Hospital, Tehran University of Medical Sciences, were included in this study. We included women that had undergone IVF treatment because of male factor, tubal factor, or unexplained infertility. The women randomly underwent controlled ovarian stimulation (COS) with either the GnRH-a (n = 26) or the GnRH-ant (n = 24). We obtained 50 germinal vesicle (GV) oocytes donated by women in each group. After the sampling, pool of 50 GV oocytes for each group was separately analyzed by quantitative polymerase chain reaction (qPCR).ResultThe expression levels of Adenosine triphosphatase 6 (ATPase 6), Bone morphogenetic protein 15 (BMP15), and Neuronal apoptosis inhibitory protein (NAIP) genes were significantly upregulated in the GnRH-ant group compared to the GnRH-a group, with the fold change of 3.990 (SD ± 1.325), 6.274 (SD ± 1.542), and 2.156 (SD ± 1.443), respectively, (P < 0.001). Growth differentiation factor 9 (GDF9) mRNA did not have any expression in the GnRH-a group; however, GDF9 mRNA was expressed in the GnRH-ant group. Finally, it was found that the genes involved in the DNA repairing and cell cycle checkpoint did not have any expression in either group.ConclusionThe present study showed, for the first time, the expression levels of genes involved in the cytoplasmic maturity (BMP15, GDF9), adenosine triphosphate production (ATPase 6), and antiapoptotic process (NAIP), in human GV oocytes were significantly higher in the GnRH-anta group than in the GnRH-a group in COS. Higher expression level of these genes when GnRH-ant protocol is applied, this protocol seems to be a more appropriate choice for women with poly cystic ovarian syndrome, because it can probably improve the expression of the aforementioned genes.Trial registrationCurrent Controlled Trials: IRCT 2014031112307 N3.

Dataset Information

Early gonadotropin-releasing hormone antagonist protocol in women with polycystic ovary syndrome: A preliminary randomized trial.

Publications

Early gonadotropin-releasing hormone antagonist protocol in women with polycystic ovary syndrome: A preliminary randomized trial.

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