scholarly journals A randomized comparison of different hormone replacement protocols for thawed blastocyst transfer

2017 ◽  
Author(s):  
Sagiri Taguchi ◽  
Miyako Funabiki ◽  
Yoshihiro Tada ◽  
Masako Karita ◽  
Terumi Hayashi ◽  
...  

AbstractBackgroundThere are no randomized controlled trials evaluating the pregnancy rates after thawed blastocyst transfers in patients treated with various hormone replacement regimens.MethodsA prospective randomized controlled trial was conducted to evaluate the outcomes in three different hormone replacement protocols for thawed blastocyst transfer. A total of 330 women (median age 38.2 years) who were undergoing IVF at our clinic were enrolled.ResultsSerum estradiol (E2) levels were 267.71 pg/ml in Premarin group, 391.22 pg/ml in Estrogel group and 495.12 pg/ml in Estrana tape group. Therefore, serum E2 levels in Estrana tape group were higher than those of the other two groups (P<0.01). The pregnancy rate in the Estrogel group was higher than that in the Premarin group (30.0% versus 17.3%, P=0.026, odds ratio 2.05, 95% confidence interval: 1.09–3.87). Furthermore, the pregnancy rate in the Estrana tape group was higher than that in the Estrogel group (43.6% versus 30.0%, P=0.036, odds ratio 1.81, 95% confidence interval: 1.04–3.14).ConclusionThe serum E2 levels contributed to differences observed in the pregnancy rate among the three different protocols. Thus, Estrana tape has an advantage as a hormone replacement protocol for thawed blastocyst transfer.

2017 ◽  
Vol 14 (4) ◽  
pp. 381-386 ◽  
Author(s):  
Amy J Morgan ◽  
Ronald M Rapee ◽  
Jordana K Bayer

Background/aims Achieving a high response rate to follow-up questionnaires in randomized controlled trials of interventions is important for study validity. Few studies have tested the value of incentives in increasing response rates to online questionnaires in clinical trials of health interventions. This study evaluated the effect of a gift card prize-draw incentive on response rates to follow-up questionnaires within a trial of an online health intervention. Method The study was embedded in a host randomized controlled trial of an online parenting program for child anxiety. A total of 433 participants were randomly allocated to one of two groups: (1) being informed that they would enter a gift card prize-draw if they completed the final study questionnaire (24-week follow-up) and (2) not informed about the prize-draw. All participants had a 1 in 20 chance of winning an AUD50 gift card after they completed the online questionnaire. Results The odds of the informed group completing the follow-up questionnaire were significantly higher than the uninformed group, (79.6% vs 68.5%, odds ratio = 1.79, 95% confidence interval = 1.15–2.79). This response rate increase of 11.1% (95% confidence interval = 2.8–19.1) occurred in both intervention and control groups in the host randomized controlled trial. The incentive was also effective in increasing questionnaire commencement (84.6% vs 75.9%, odds ratio = 1.74, 95% confidence interval = 1.07–2.84) and reducing the delay in completing the questionnaire (19.9 vs 22.6 days, hazard ratio = 1.34, 95% confidence interval = 1.07–1.67). Conclusion This study adds to evidence for the effectiveness of incentives to increase response rates to follow-up questionnaires in health intervention trials.


2021 ◽  
Author(s):  
Marouf Muhammad Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha

Abstract Background: Antibiotic-resistant reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, lead to varying treatment protocols according to locations. The primary outcome of this research is to estimate the eradication rates of modified bismuth quadruple versus modified levofloxacin concomitant as empirical first-line treatment by intention to treat analysis (ITT) and per-protocol analysis (PPA) in a referral hospital in Syria.Settings and Design: an open‑label parallel blind randomized controlled trial.Methods: We randomly assigned seventy-eight naïve who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (B-group) which receive (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for two weeks), or (L-group) which receive (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test at eight weeks.Results: Thirty-nine patients were allocated in each group. In the B- group, thirty-eight patients completed the follow-up, thirty patients were cured. While in the L-group, thirty-nine completed the follow-up, thirty-two patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the B-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454-4.146]. According to PPA, the eradication rates were 78.9 %, and 82.1% for the B-group and L-groups respectively. The odds ratio with 95% confidence interval was 1.219 [0.394-3.774]. We didn’t report serious adverse effects.Conclusions: The eradication rates in both therapy regimes were fair. Further researches are required to help select the optimum first-line treatment for Helicobacter-Pylori Infection in the Syrian population.Trial registration: We register this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier‑NCT04348786, date:29-January-2020, https://clinicaltrials.gov/ct2/show/NCT04348786).


Author(s):  
Neeta Singh ◽  
Rohitha Cheluvaraju ◽  
Sunesh Kumar Jain

Background: Implantation failure is a major challenge in in-vitro fertilization (IVF) cycles. The present study was undertaken to determine the immunomodulatory effects of heparin in patients with previous implantation failures undergoing assisted reproductive techniques (ART).Methods: This was a prospective randomized controlled trial with sample size of 100 patients who had history of at least one previously failed IVF/ICSI. Study group of 50 patients received heparin and 50 patients in control group received routine luteal phase support.Results: Primary outcome of the study was implantation rate (IR) which was 11.03% in the study group was and 5.48% in the control group (p=0.08). Biochemical pregnancy rate and clinical pregnancy rate in the study group was 18% and 12% in the control group (p=0.401). Calculated live birth was 5.15% and 3.42% in the study and control groups respectively (p=0.562). 11 babies were taken home from the study group and 6 from the control group (p=0.18).Conclusions: The result of this pilot study showed relative increase in implantation rates (IR) suggesting beneficial effects of heparin in patients with repeated implantation failures. Although these changes are not statistically significant, the presence of an increasing trend in all the outcome parameters signify the possible benefits of heparin proving for the present study hypothesis.


2019 ◽  
Vol 33 (8) ◽  
pp. 1331-1343 ◽  
Author(s):  
Jacqui H Morris ◽  
Alexandra John ◽  
Lucy Wedderburn ◽  
Petra Rauchhaus ◽  
Peter T Donnan

Objective: The aim of this study was to explore the feasibility of conducting a randomized controlled trial of dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke and to explore the magnitude and direction of change on arm outcomes. Design: This is a single-blind, two-arm parallel group, feasibility randomized controlled trial. Setting: In-patient rehabilitation. Subjects: The study participants were stroke survivors with arm hemiparesis two to four weeks after stroke receiving in-patient rehabilitation. Interventions: Participants were randomized 2:1 to wear Lycra® gauntlets for eight hours daily for eight weeks, plus usual rehabilitation ( n = 27), or to usual rehabilitation only ( n = 16). Main measures: Recruitment, retention, fidelity, adverse events and completeness of data collection were examined at 8 and 16 weeks; arm function (activity limitation; Action Research Arm Test, Motor Activity Log) and impairment (Nine-hole Peg Test, Motricity Index, Modified Tardieu Scale). Structured interviews explored acceptability. Results: Of the target of 51, 43 (84%) participants were recruited. Retention at 8 weeks was 32 (79%) and 24 (56%) at 16 weeks. In total, 11 (52%) intervention group participants and 6 (50%) control group participants (odds ratio = 1.3, 95% confidence interval = 0.2 to 7.8) had improved Action Research Arm Test level by 8 weeks; at 16 weeks, this was 8 (61%) intervention and 6 (75.0%) control participants (odds ratio = 1.1, 95% confidence interval = 0.1 to 13.1). Change on other measures favoured control participants. Acceptability was influenced by 26 adverse reactions. Conclusion: Recruitment and retention were low, and adverse reactions were problematic. There were no indications of clinically relevant effects, but the small sample means definitive conclusions cannot be made. A definitive trial is not warranted without orthoses adaptation.


2021 ◽  
Author(s):  
Marouf Muhammad Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha

Abstract Background: Antibiotic-resistant reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, lead to varying treatment protocols according to locations. The primary outcome of this research is to estimate the eradication rates of modified bismuth quadruple versus modified levofloxacin concomitant as empirical first-line treatment by intention to treat analysis (ITT) and per-protocol analysis (PPA) in a referral hospital in Syria.Settings and Design: an open‑label parallel blind randomized controlled trial.Methods: We randomly assigned seventy-eight naïve who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (B-group) which receive (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for two weeks), or (L-group) which receive (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test at eight weeks. Results: Thirty-nine patients were allocated in each group. In the B- group, thirty-eight patients completed the follow-up, thirty patients were cured. While in the L-group, thirty-nine completed the follow-up, thirty-two patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the B-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454-4.146]. According to PPA, the eradication rates were 78.9 %, and 82.1% for the B-group and L-groups respectively. The odds ratio with 95% confidence interval was 1.219 [0.394-3.774]. We didn’t report serious adverse effects. Conclusions:The eradication rates in both therapy regimes were fair. Further trials are intended to help select the right first-line treatment for Helicobacter-Pylori Infection in the Syrian population.Trial registration: We register this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier‑NCT04348786, date:29-January-2020, https://clinicaltrials.gov/ct2/show/NCT04348786).


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Hisham M Fathy ◽  
Ahmed M BahaaEldin ◽  
Sarah Safwat ◽  
Elham R Mohammed

Abstract Background There is controversy regarding treatment of unexplained infertility due to absence of specific pathophysiological rational which allows curative intervention. The main three lines of treatment of such cases are confrolled ovarian hyperstimulation, IUI with spontaneous or induced ovulation and third is IVF. Aim of the Work to evaluate the effect of metformin on chemical pregnancy rate in women with unexplained infertility. Patients and Methods: This was a prospective randomized controlled trial study which was conducted on 170 women with unexplained infertility in Ain Shams Maternity Hospital. Results :. Incidence of chemical pregnancy was not statistically sigfificantly different between both groups (PR: 18.8% vs.16.5% P 0.84) in metfonnin and clomiphene y•oup respectively. (NNT) was estimated to be 42.5. Conclusion our study showed little benefit was added to the patients by using metfonnin as adjuvant therapy to clomiphene citrate during ovulation induction as regards chemical pregnancy. 42 women are needed to be freated with metformin to get one more pregnant woman by pregnancy test


Author(s):  
Apurba Mandal ◽  
Shibram Chattopadhyay ◽  
Chandan Sasmal ◽  
Tapan Kumar Maiti ◽  
Shritanu Bhattacharyya

Background: About 15% married couples face problem of infertility of which male factor is implicated in 20% of them. In about 30% infertile men no causative factor is found and the condition is termed “Idiopathic”. They are often treated by empirical medications or Assisted Reproductive Technologies (ART) although success in few; our present study is carried on effects of clomephene citrate on seminal parameters in idiopathic oligospermia.Methods: This single blinded prospective randomized controlled trial was conducted at the infertility clinic with 200 idiopathic oligospermic men (sperm count <15 millions/ ml of ejaculate) after fulfilling inclusion and exclusion criteria and were alternately allocated into two equal groups - “Group C” receiving clomephene citrate tablets and “ Group P” receiving placebo after concealment. Semen analysis data were collected at baseline and every month and three months of completion of treatment and were summarized by routine descriptive statistical analysis.Results: The demographic characteristics like mean age is comparative in both groups but duration of infertility of >2 years is more in group C than group p (4.3±3.06 versus 4.1±2.57). The semen volume, spermatozoa count, sperm motility and not normal form are all increased after three months of treatment in group C as are biochemical parameters like total testosterone and serum FSH, LH and as also pregnancy rate (22% versus 4%).Conclusions: This study showed clomiphene citrate treatment protocol is inexpensive, relatively safe and easy to administer and improves semen volume, sperm count and sperm motility but not sperm morphology by increasing serum testosterone, FSH and LH in male and resulting in improved pregnancy rate in female partners.


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