Improving the Reporting of Clinical Trials of Infertility Treatments IMPRINT Modifying the CONSORT statement

Capsule:
We propose a modification of the CONSORT checklist for randomized infertility trials to increase reporting of live birth and all harms to participating subjects including parents and resulting fetuses/infants.

Author:
XiaoKe Wu, M.D., Ph.D.

Volume 102, Issue 4, Pages 952-959

Abstract:

Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which creates a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant after ≥20 weeks’ gestation) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples.

Casting for determinants of blastocyst yield and of rates of implantation and of pregnancy after blastocyst transfers

Capsule:
Numbers of oocytes retrieved and properties of day 3 embryos were predictive of blastocyst formation, implantation, and pregnancy. Patient age and oocyte yields independently impacted implantation rates and uterine receptivity.

Authors:
Bronte Allan Stone, Ph.D., Charles M. March, M.D., Guy E. Ringler, M.D., Kelly J. Baek, M.D., Richard P. Marrs, M.D.

Abstract:

Volume 102, Issue 4, Pages 1055-1064

Objective:
To identify determinants of blastocyst yield, implantation rate, and pregnancy outcome.

Design:
Retrospective analysis of outcomes of 1,653 cycles of IVF.

Setting:
Private infertility clinic.

Patient(s):
Couples presenting to an infertility clinic for IVF.

Intervention(s):
None.

Main Outcome Measure(s):
Blastocyst yield, implantation rate, and pregnancy.

Result(s):
Of a broad array of potential determinants, only the total numbers of oocytes retrieved and properties of day 3 embryos were consistently predictive of blastocyst formation. Relative to numbers of oocytes fertilized by intracytoplasmic sperm injection (ICSI), yields of quality blastocysts were highest in cycles in which <10 oocytes were retrieved. Blastocyst yield was closely linearly correlated with average numbers of blastomeres in embryos on day 3. As oocyte yields rose, average grades and the implantation potential of the blastocysts selected for transfer increased by approximately 0.015 and 0.15%, respectively, for each additional oocyte. Independently, the implantation potential of blastocysts decreased 1.1% for each advancing year in age of the oocyte provider, and, for autologous transfers, uterine receptivity declined an additional 0.6% per year. Higher yields of blastocysts from cycles with high oocyte numbers afforded better selection of blastocysts for transfer, supporting higher overall implantation and pregnancy rates.

Conclusion(s):
While the proportion of fertilized oocytes that progressed to quality blastocysts diminished as numbers of recovered oocytes rose, rates of implantation and pregnancy after transfer of the selected best blastocysts increased. The age of the oocyte provider and oocyte yields independently impacted blastocyst implantation potential and uterine receptivity after controlled ovarian hyperstimulation, ICSI, and blastocyst transfer.

Semen quality of consecutive ejaculates from cancer patients for fertility preservation

Capsule:
This is the first study showing that repeated ejaculates from cancer patients did not show substantial variation in semen quality.

Authors:
Seul Ki Kim, M.D., Jang Mi Lee, B.S., Byung Chul Jee, M.D., Ph.D., Chang Suk Suh, M.D., Ph.D., Seok Hyun Kim, M.D., Ph.D.

Volume 102, Issue 4, Pages 1124-1129

Abstract:

Objective:
To study variations in semen parameters among cancer patients who visited a sperm banking clinic before undergoing cancer treatment.

Design:
Retrospective, consecutive study.

Setting:
University-based hospital.

Patient(s):
Eighty-six patients, diagnosed with various cancers, undergoing multiple semen collections on 5 consecutive days, for fertility preservation, between 2004 and 2013.

Intervention(s):
None.

Main Outcome Measures:
Within- and between-subject coefficients of variation were estimated using a random-effects analysis of variance to assess the consistency of semen parameters (volume, sperm concentration, motility, rapid motility, total motile sperm count, and computer-based sperm parameters), whereas intraclass correlation coefficients (ICCs) were calculated to assess the size of the between-component of variance relative to the total component of variance.

Result(s):
When analyzing semen parameters over a maximum of 5 consecutive days, only the semen volume was significantly reduced in day-1 and -3 samples compared with the first sample. Almost all of the parameters showed high ICC values, suggesting that within-subject fluctuations were small relative to the between-subject variability. The highest ICC values were noted in volume (ICC 0.76; 95% confidence interval [CI] 0.52–0.89), followed by total motile count (ICC 0.71; 95% CI 0.30–0.89); the least consistent measure was wobble (ICC 0.14; 95% CI −0.13, 0.51).

Conclusion(s):
Repeated ejaculates from cancer patients did not show substantial variation in semen quality.

Articles of Special Interest

Improving the Reporting of Clinical Trials of Infertility Treatments IMPRINT Modifying the CONSORT statement

Friday, August 1, 2014
We propose a modification of the CONSORT checklist for randomized infertility trials to increase reporting of live birth and all harms to participating subjects including parents and resulting fetuses/infants.

Casting for determinants of blastocyst yield and of rates of implantation and of pregnancy after blastocyst transfers

Monday, June 30, 2014
Numbers of oocytes retrieved and properties of day 3 embryos were predictive of blastocyst formation, implantation, and pregnancy. Patient age and oocyte yields independently impacted implantation rates and uterine receptivity.

Semen quality of consecutive ejaculates from cancer patients for fertility preservation

Monday, June 30, 2014
This is the first study showing that repeated ejaculates from cancer patients did not show substantial variation in semen quality.

Is subfertility or fertility treatment associated with long term growth in the offspring A cohort study

Friday, June 27, 2014
Compared with children born to fertile parents, no systematic differences were observed for body weight, height, body mass index, or head circumference at age 5 in children conceived after fertility treatment or in children born to subfertile parents.