scholarly journals IVF and IUI in couples with unexplained infertility (FIIX study): study protocol of a non-inferiority randomized controlled trial

2020 ◽  
Vol 2020 (3) ◽  
Author(s):  
Lucy Prentice ◽  
Lynn Sadler ◽  
Sarah Lensen ◽  
Melissa Vercoe ◽  
Jack Wilkinson ◽  
...  
Keyword(s):  
Live Birth ◽  
Ovarian Stimulation ◽  
Lower Cost ◽  
Controlled Trial ◽  
Clomiphene Citrate ◽  
Multiple Pregnancy ◽  
Unexplained Infertility ◽  
Live Births ◽  
Randomized Controlled ◽  
Natural Conception

Abstract STUDY QUESTIONS In couples with unexplained infertility and a poor prognosis of natural conception, are four cycles of IUI with ovarian stimulation (IUI-OS) non-inferior to one completed cycle of IVF for the outcome of cumulative live birth? Are four cycles of IUI-OS associated with a lower cost per live birth compared to one completed cycle of IVF? Will four cycles of IUI-OS followed by one complete cycle of IVF result in as many live births at lower cost per live birth, than two complete cycles of IVF? Will four cycles of IUI-OS followed by two complete cycles of IVF result in more live births at lower cost per live birth, than two complete cycles of IVF alone? WHAT IS KNOWN ALREADY IUI is widely used in the USA, the UK and Europe as a low cost, less invasive alternative to IVF for couples with unexplained infertility. Although three to six cycles of IUI were comparable to IVF in the three major studies carried out to date, gonadotrophin ovarian stimulation was used in the majority of cases, and this also resulted in a high multiple pregnancy rate in some studies. Ovarian stimulation with clomiphene citrate is known to have lower multiple pregnancy rates. STUDY DESIGN, SIZE, DURATION The FIIX study is a multicentre, open label, parallel, pragmatic non-inferiority randomized controlled trial of 580 couples with unexplained infertility comparing four cycles of IUI-OS with clomiphene citrate and one completed cycle of IVF. Variable block randomization stratified by age and clinic with electronic allocation will be used. PARTICIPANTS/MATERIALS, SETTING, METHODS Couples with poor prognosis for natural conception and who are eligible for publicly funded fertility treatment in six fertility clinics in New Zealand. STUDY FUNDING/COMPETING INTEREST(S) Auckland Medical Research Fund (3718892/1119003), A+ Trust, Auckland District Health Board (A + 8479), Maurice and Phyllis Paykel Trust (3718514). No competing interests. TRIAL REGISTRATION NUMBER ACTRN12619001003167. TRIAL REGISTRATION DATE 15 July 2019 DATE OF FIRST PATIENT’S ENROLMENT 02/08/2019

scholarly journals Acupuncture and Clomiphene Citrate for Live Birth in Polycystic Ovary Syndrome: Study Design of a Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Hongying Kuang ◽  
Yan Li ◽  
Xiaoke Wu ◽  
Lihui Hou ◽  
Taixiang Wu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Polycystic Ovary Syndrome ◽  
Live Birth ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Clomiphene Citrate ◽  
Fertility Treatment ◽  
Ovary Syndrome ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Acupuncture is an alternative therapy to induce ovulation in women with polycystic ovary syndrome (PCOS), but there is no study reporting the live birth rate following ovulation induction by acupuncture or its potential as an adjuvant treatment to clomiphene citrate (CC). We assess the efficacy of acupuncture with or without CC in achieving live births among 1000 PCOS women in Mainland China. This paper reports the methodology of an ongoing multicenter randomized controlled trial. The randomization scheme is coordinated through the central mechanism and stratified by the participating sites. Participants will be randomized into one of the four treatment arms: (A) true acupuncture and CC, (B) control acupuncture and CC, (C) true acupuncture and placebo CC, and (D) control acupuncture and placebo CC. To ensure the quality and integrity of the trial we have developed a unique multinational team of investigators and Data and Safety Monitoring Board. Up to the end of April 2013, 326 subjects were recruited. In conclusion, the success of this trial will allow us to evaluate the additional benefit of acupuncture beyond the first line medicine for fertility treatment in PCOS women in an unbiased manner.

scholarly journals Cumulative live birth rates after weight reduction in obese women scheduled for IVF: follow-up of a randomized controlled trial

2019 ◽  
Vol 2019 (4) ◽  
Author(s):  
L Kluge ◽  
C Bergh ◽  
S Einarsson ◽  
A Pinborg ◽  
A-L Mikkelsen Englund ◽  
...  
Keyword(s):  
Live Birth ◽  
Weight Reduction ◽  
Birth Rate ◽  
Controlled Trial ◽  
Live Birth Rate ◽  
Obese Women ◽  
Live Births ◽  
Randomized Controlled ◽  
Cumulative Live Birth

Abstract STUDY QUESTION Did weight reduction in obese women scheduled for IVF increase cumulative live birth rate (CLBR) after 2 years? SUMMARY ANSWER Weight loss prior to IVF did not increase CLBR. WHAT IS KNOWN ALREADY Few studies have investigated the effect of weight reduction in obese infertile women scheduled for IVF. In a recent randomized controlled trial (RCT), including one IVF cycle, we found no increase in live birth rate after weight reduction. Weight regain after obesity reduction treatment often occurs, and children born to obese women have a higher risk of childhood obesity. STUDY DESIGN, SIZE, DURATION A 2-year follow-up of a multicenter, RCT running between 2012 and 2018 was performed. Out of 317 women randomized to weight reduction followed by IVF treatment or IVF treatment-only, 305 remained in the full analysis set. Of these women, 90.5% (276/305) participated in this study. PARTICIPANTS/MATERIALS, SETTING, METHODS Nine infertility clinics in Sweden, Denmark and Iceland participated in the RCT. Obese women under 38 years of age having a BMI ≥30 and < 35 kg/m2 were randomized to weight reduction and IVF or IVF-only. In all, 160 patients were randomized to a low calorie diet for 12 weeks and 3–5 weeks of weight stabilization, before IVF and 157 patients to IVF-only. Two years after randomization, the patients filled in a questionnaire regarding current weight, live births and ongoing pregnancies. MAIN RESULTS AND THE ROLE OF CHANCE 42 additional live births were achieved during the follow-up in the weight reduction and IVF group, and 40 additional live births in the IVF-only group, giving a CLBR, the main outcome of this study, of 57.2% (87/152) and 53.6% (82/153), respectively (P = 0.56; odds ratio (OR) 1.16, 95% CI: 0.74–1.52). Most of the women in the weight reduction and IVF group had regained their pre-study weight after 2 years. The mean weight gain over the 2 years was 8.6 kg, while women in the IVF-only group had a mean weight loss of 1.2 kg. At the 2-year follow-up, the weight standard deviation scores of the children born in the original RCT (index cycle) were 0.218 (1.329) (mean, SD) in the weight reduction and IVF group and − 0.055 (1.271) (mean, SD) in the IVF-only group (P = 0.25; mean difference between groups, 0.327; 95% CI: −0.272 to 0.932). LIMITATIONS, REASON FOR CAUTION All data presented in this follow-up study were self-reported by the participants, which could affect the results. A further limitation is in power for the main outcome. The study is a secondary analysis of a large RCT, where the original power calculation was based on live-birth rate after one cycle and not on CLBR. WIDER IMPLICATIONS OF THE FINDINGS The follow-up indicates that for women with a BMI ≥30 and < 35 kg/m2 and scheduled for IVF, the weight reduction did not increase their chance of a live birth either in the index cycle or after 2 years. It also shows that even in this highly motivated group, a regain of pre-study weight occurred. STUDY FUNDING/COMPETING INTEREST(S) The 2-year follow-up was financed by grants from the Swedish state under the agreement between the Swedish Government and the county councils, the ALF-agreement (ALFGBG-70940 and ALFGBG-77690), Merck AB, Solna, Sweden (an affiliate of Merck KGaA, Darmstadt, Germany), Hjalmar Svensson Foundation. Ms Kluge has nothing to disclose. Dr Bergh has been reimbursed for lectures and other informational activities (Ferring, MSD, Merck, Gedeon Richter). Dr Einarsson has been reimbursed for lectures for Merck and Ferring. Dr Thurin-Kjellberg reports grants from Merck, and reimbursement for lectures from Merck outside the submitted work. Dr Pinborg has been reimbursed for lectures and other informational activities (Ferring, MSD, Merck, Gedeon Richter). Dr Englund has nothing to disclose. TRIAL REGISTRATION NUMBER ClinicalTrials.gov number, NCT01566929.

scholarly journals Effect of Hydrotubation in Unexplained Infertility – A Randomized Controlled Trial

2016 ◽  
Vol 22 (3) ◽  
Author(s):  
Shazia Saaqib ◽  
Muhammad Arshad Chohan ◽  
Misbah Ashraf ◽  
Ammara Mumtaz
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clomiphene Citrate ◽  
Unexplained Infertility ◽  
Control Group ◽  
Fallopian Tubes ◽  
Randomized Controlled ◽  
Tubal Blockage ◽  
Study Participants ◽  
And Control

<p>Unexplained infertility is a major gynecological problem with complex etiolgy. Partial tubal blockage with inflammatory reaction and thick mucus plugs in fallopian tubes and cervix is one of the likely causes in such cases. This study is based on the hypothesis that women having unexplained infertility could be helped by transcervical flushing of fluid through the fallopian tubes which would remove reversible blocking factors and help in achieving pregnancy.</p><p><strong>Objective:</strong><strong>  </strong>To compare the outcome of hydrotubation<br /> in unexplained infertility in clomiphene citrate stimulated cycles with control group (no Hydrotubation).</p><p><strong>Setting:</strong><strong>  </strong>Infertility Centre of a Public Sector Hospital.</p><p><strong>Study Design:</strong><strong>  </strong>A two years Prospective randomized controlled trial from Jan 2014 to Dec 2015.</p><p><strong>Method:</strong><strong>  </strong>128 women participated in the study. Participants were divided into study and control group with 64 members in each group. Ovulation induction was done with clomiphene citrate in all the participants and confirmed by ovulation detection strips and follicular tracking on Ultrasonography. 50 cc cocktail of inject-ion (inj.) kanamycin 1 gm, inj. hydrocortisone and normal saline was injected transcervically in study group for three consecutive days from the next day after end of menstruation. No hydrotubation was done in control group. Main outcome measures were number of conceptions within next 3 cycles and complications of hydrotubation.</p><p><strong>Results:</strong><strong>  </strong>In hydrotubation group, 20 women conceived. Out of these, 14 women conceived in the same cycle in which hydrotubation was done while 6 pregnancies occurred in subsequent cycle. 4 pregnancies occurred in the control group. Complications of hydrotubation were mild abdominal pain (59 women), vomiting (49 women) and Per vaginum bleeding (18 women). There were significantly more pregnancies in women who experienced right shoulder tip pain after the procedure.</p><p><strong>Conclusion:</strong><strong>  </strong>In women with unexplained infertility, tubal hydration can increase conception rate and decrease the time to achieve pregnancy.</p><p> </p>

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