Objective: To compare metformin and combined oral contraceptive pill (COC) effects over 24 months in adolescent PCOS. Design: Randomized controlled study. Setting: Alexandria ICSI centre. Patients: 117 adolescent girls with PCOS, were randomized to: group A (n = 40): metformin, group B (n = 40): COC, and group C (n = 39): control. Interventions: Group A: received metformin, group B: received combined oral contraceptives. Main outcome measures: Improvement in cycle rhythm and hirsutism. Results: In group B a significant decline in serum testosterone reached the lowest value by the end of the second year (0.7 ± 0.2 versus 1.3 ± 0.5 lg/ml). By the end of the study, group A showed a significant decline in fasting (18.6 ± 3.0-10.0 ± 3.0 lIU/ml) and after-load insulin levels (126 ± 43-64 ± 15 lIU/ml) with a significant rise in glucose/insulin ratio (GIR) from 4.1 ± 0.3 to 4.6 ± 0.5. Group B showed a significant rise in fasting and after-load insulin (from 15.0 ± 3.0 lIU/ml and 103.0 ± 91.0 lIU/ml to 19.0 ± 4.0 and 187.0 ± 22.0 lIU/ml, respectively) and GIR dropped significantly from 4.4 ± 0.2 to 3.1 ± 0.3. Metformin was associated with a significant loss of weight from 87.0 ± 6.0 to 72.0 ± 0.5 kg while COC was associated with a non-significant gain in weight (from 84.0 ± 6.0 to 91.0 ± 9.0 kg). Conclusions: Metformin and COC have comparable therapeutic effectiveness on cycle regularity and hirsutism. Metformin was associated with a significant improvement in met-* Corresponding author at

Objective To prepare a set of statements for randomised clinical trials (RCT) integrity through an international multi‐stakeholder consensus. Methods The consensus was developed via: multi‐country multidisciplinary stakeholder group composition and engagement; evidence synthesis of 55 systematic reviews concerning RCT integrity; anonymised two‐round modified Delphi survey with consensus threshold based on the average percentage of majority opinions; and, a final consensus development meeting. Prospective registrations: (https://osf.io/bhncy, https://osf.io/3ursn). Results There were 30 stakeholders representing 15 countries from five continents including triallists, ethicists, methodologists, statisticians, consumer representatives, industry representatives, systematic reviewers, funding body panel members, regulatory experts, authors, journal editors, peer‐reviewers and advisors for resolving integrity concerns. Delphi survey response rate was 86.7% (26/30 stakeholders). There were 111 statements (73 stakeholder‐provided, 46 systematic review‐generated, 8 supported by both) in the initial long list, with eight additional statements provided during the consensus rounds. Through consensus the final set consolidated 81 statements (49 stakeholder‐provided, 41 systematic review‐generated, 9 supported by both). The entire RCT life cycle was covered by the set of statements including general aspects (n = 6), design and approval (n = 11), conduct and monitoring (n = 19), reporting of protocols and findings (n = 20), post‐publication concerns (n = 12), and future research and development (n = 13). Conclusion Implementation of this multi‐stakeholder consensus statement is expected to enhance RCT integrity.

26/6/2015.

No abstract

Higher stimulation day-six estradiol was associated with a higher probability of cryopreservation, and a higher pregnancy rate.